Monday report

OPM

Monday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Medical / Rx research, Medicare, NCQA, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “Top Democrats made their case to President Trump for restoring billions of dollars in healthcare spending as part of any deal to avoid a government shutdown, but they said there was no breakthrough in talks, further dimming hopes of a last-minute deal.
    • “It was a frank and direct discussion” with the president and Republican leaders, “but significant and meaningful differences remain,” said House Minority Leader Hakeem Jeffries (D., N.Y.) after leaving the meeting at the White House.” * * *
    • “The open question headed into Monday’s meeting was whether Trump the dealmaker would show up, or if he was content to let Democrats go home empty-handed. Trump believes he is in a strong position and that Democrats will be blamed for shutting down the government, according to allies. A Republican close to the talks said that while Trump likes to be a dealmaker, there may not be much of a deal to be made.
    • “[Senate Minority Leader Chuck] Schumer [D., N.Y.] and Senate Majority Leader John Thune (R., S.D.) have signaled any deal would likely focus on extending health-insurance subsidies. Those enhanced Affordable Care Act tax credits, first passed in 2021 by Democrats, are set to expire at year’s end. Democrats and some Republicans want an extension, but Republicans are seeking some new income limits on who receives subsidies. They also say discussions should only take place after Congress passes the stopgap bill keeping the government funded through late November.
    • The Senate was set to vote again before the Wednesday deadline on the same GOP bill that Democrats had previously rejected. Republicans have a 53-47 majority, but they need 60 votes to pass most legislation. With the House out this week, that is currently the only option available.
  • Modern Healthcare adds,
    • “The federal government is on track to shut down at midnight EST Wednesday, when fiscal 2026 begins. President Donald Trump and the Republican-led Congress have failed to enact annual appropriations bills to finance government operations. Negotiations with Senate Democrats continued Monday.
    • “Medicare, Medicaid, the Children’s Health Insurance Program and the federal health insurance exchanges would continue operating for the immediate future, HHS announced. The first three programs are mandatory and not subject to annual appropriations and CMS would cover exchange expenses with insurance company user fees.”
  • Federal News Network reminds us,
    • “Even if an agency doesn’t pay health premiums on time to OPM, federal employees and other enrollees in the Federal Employees Health Benefits (FEHB) program, as well as participants in the Postal Service Health Benefits (PSHB) program, maintain coverage throughout the duration of a shutdown, OPM has said in shutdown guidance.
    • “Those same rules apply to coverage through the Federal Employees Dental and Vision Insurance Program (FEDVIP), the Federal Employees’ Group Life Insurance (FEGLI) program and the Federal Long Term Care Insurance Program (FLTCIP).
    • “While all FEHB and PSHB participants maintain health coverage during a shutdown, those who are excepted or furloughed are not expected to pay health premiums while a shutdown is ongoing. Enrollees, however, will have to make any payments for premiums that accumulate during a shutdown, once the shutdown ends.”
  • Govexec offers part 2 of a series of commentaries about OPM in the second Trump Administration while FedSmith reminds folks about five mistakes to avoid during the upcoming FEHB / PSHB / FedFlex Open Season.
  • Avalere Health calls attention to key health policy actions to watch for during the rest of this year.
  • Mercer Consulting informs us,
    • “The 2026 changes to the Medicare Part D drug benefit passed under the Inflation Reduction Act are generally modest compared to the significant adjustments made in 2025. However, new instructions related to determining the creditable coverage status of prescription drug coverage allow plan sponsors to utilize a revised methodology for 2026. Plan sponsors should review the new methodology as they determine the most suitable one for their particular group health plan.
    • “Prior to Oct. 15 each year, plan sponsors providing prescription drug coverage must notify Part D-eligible individuals enrolled, or seeking to enroll, in their group health plan about whether the plan’s drug coverage is creditable — generally, whether it’s expected to pay, on average, at least as much as the Part D standard prescription drug coverage. Additionally, plan sponsors are required to report the creditable coverage status of their prescription drug plans to the Centers for Medicare and Medicaid Services each year, within 60 days of the plan year’s start.
    • “The IRA significantly enhanced Medicare Part D beginning in 2025, raising concerns among some plan sponsors about whether their drug coverage would remain creditable.  Instructions provided by CMS for 2026 take into account the IRA’s enhancements and increased flexibility in how plan sponsors may determine whether their drug coverage is creditable going forward, updating their Simplified Determination Methodology for 2026. And for the first time, some Health Savings Account-qualifying High-Deductible Health Plans may be able to use the SDM to determine creditable coverage status.”
  • The American Hospital Association News tells us,
    • “The Office of Science and Technology Policy issued a request for information Sept. 26 seeking feedback on federal regulations that hinder AI development, deployment or adoption. The OSTP is requesting comments on regulations across all sectors, including health care, where the underlying assumptions, technical requirements or compliance frameworks may create unnecessary barriers to beneficial AI applications. The agency is accepting comments through www.regulations.gov until Oct. 27.”
  • and
    • “The AHA Sept. 29 sent recommendations to the Department of Health and Human Services and the Centers for Medicare & Medicaid Services to help ensure insurance plans adhere to the agencies’ health insurer pledge to reform prior authorization processes. They include monitoring plans’ progress in fully implementing existing regulations, such as the interoperability and prior authorization final rule and reforms issued in the 2024 Medicare Advantage final rule. “As a result of the enormous detrimental impact that certain prior authorization practices routinely place on patients, physicians and hospitals, the AHA has been actively pushing for reforms in this area for a long time and working with health plans to collaboratively reduce the burdens associated with these programs,” the AHA wrote.”
  • and
    • “The AHA Sept. 29 asked the Trump administration to provide exemptions for health care personnel from the proclamation issued Sept. 19 announcing changes to the H-1B visa program. The proclamation increases the fee to $100,000 for new H-1B petitions filed by employers, as well as implements other restrictions on the entry of certain nonimmigrant workers. Of nearly 400,000 H-1B petitions approved in fiscal year 2024, 16,937 of those, or 4.2% of the total filed petitions, were for medicine and health occupations, and half of those approved petitions were for physicians and surgeons.” 
  • The Labor Department’s Bureau of Labor Statistics issued its annual report
    • “Seventy-two percent of private industry workers had access to medical care plans and 45 percent of workers participated. Dental care was available to 30 percent of private industry workers in establishments with less than 100 workers, 50 percent of private industry workers in establishments with 100-499 workers, and 70 percent of private industry workers in establishments with 500 workers or more. Vision care benefits were available for 21 percent of workers in establishments with less than 100 workers, 34 percent of private industry workers in establishments with 100-499 workers, and 44 percent of private industry workers in establishments with 500 workers or more. on employee benefits in the United States.
  • Per Beckers Payer Issues,
    • “The National Committee for Quality Assurance has named Vivek Garg, MD, as its next president and CEO, effective Jan. 5.
    • “Dr. Garg succeeds NCQA founder and current president Margaret O’Kane, who will retire at the end of this year. He currently serves as chief medical officer at Humana’s CenterWell Senior Primary Care.
    • “Dr. Garg previously held leadership positions at CareMore and Aspire Health, Oscar Health and One Medical Group.”

From the Food and Drug Administration front,

  • Fierce Pharma lets us know,
    • “Kedrion Biopharma has scored an FDA approval for Qivigy for adults with primary humoral immunodeficiency (PI), a group of disorders that prevent the immune system from operating effectively. 
    • “As an intravenous immunoglobulin (IVIG) therapy, Qivigy provides patients with antibodies that are intended to help them ward off infections.
    • “Along with the approval, the Italian plasma collection specialist was quick to point out in a release that it plans to increase its investments in the United States. To support the production of Qivigy, Kedrion announced plans to invest more than $260 million in expanding its U.S. network with over 40 new plasma collection centers. 
    • “The company also said it will invest more than $60 million to expand capacity at its manufacturing facility in Melville, New York.”
  • and
    • “Johnson & Johnson’s Tremfya continues to expand its reach as now the FDA has approved the IL-23 inhibitor as a treatment for two pediatric patient populations.
    • “The agency endorsed Tremfya as a treatment for children 6 years and older who weigh at least 40 kg (88 pounds) with moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy.
    • “In addition, children 6 and older with active psoriatic arthritis are now eligible for the drug, provided they weigh at least 40 kg, J&J said in a Sept. 29 release.”

From the public health and medical / Rx research front,

  • MedPage Today reports,
    • “About 58 million pounds of corn dogs and other sausage-on-a-stick products were recalled across the U.S. because pieces of wood may be embedded in the batter. (AP)
    • Meanwhile, supermarket chain Albertsons recalled several of its store-made deli products because they may contain Listeria, shortly after federal health officials warned consumers not to eat certain pasta meals sold at Walmart and Trader Joe’s over Listeria concerns. (AP)
  • and
    • “Widespread HPV vaccination slashed infection risk and delivered protection for vaccinated and unvaccinated adolescent girls and young women alike, according to a cross-sectional analysis of six regional surveillance studies.
    • “Between 2006 and 2023, the adjusted proportion of vaccinated women in the six studies who were positive for the high-risk HPV-16 and HPV-18 types covered by the first FDA-approved 2-valent HPV vaccine (2vHPV) dropped 98.4%, said Jessica Kahn, MD, MPH, of Albert Einstein College of Medicine in New York City, and colleagues.
    • “In the 17-year period, the proportion of vaccinated women who tested positive for HPV types covered by the later 4-valent vaccine (4vHPV) dropped 94.2% and fell 75.7% for types covered by the current 9-valent vaccine (9vHPV).
    • “Those declines were paired with evidence of herd protection. The proportion of unvaccinated adolescent girls and young women who were positive for at least one HPV type covered by 2vHPV dropped 71.6%. The proportion positive for at least one HPV type covered by 4vHPV fell 75.8%, they noted in JAMA Pediatrics.”
  • and
    • “In the Southern Hemisphere, the adjusted flu vaccine effectiveness rates against outpatient visits and hospitalizations were 50.4% and 49.7%.
    • “Only 21.3% of flu outpatients and 15.9% of hospitalized flu patients were vaccinated.
    • “Health authorities in the Northern Hemisphere might expect similar levels of protection against influenza, experts said.”
  • STAT News notes,
    • “Heart attacks, heart failure, and strokes don’t come out of nowhere, a new study concludes. The first time they strike, patients, clinicians, and researchers might think there were no red flags.  
    • “But a prospective cohort study reports that more than 99% of people who experienced these illnesses had at least one of four risks for cardiovascular disease. They had “suboptimal” high blood pressure, cholesterol, or blood glucose, or they were current or former smokers. More than 93% of the more than 9.3 million people in two national cohorts followed for 20 years had more than one risk factor.
    • “Among women under 60, often considered to be at lowest risk, more than 95% had at least one nonoptimal risk factor before heart failure or stroke.
    • “This almost universal prevalence of warning signs is far higher than reported in other studies, the new paper asserted.
    • “Every practicing cardiologist has seen cases in which individuals without any known risk factors sustain an MI or develop significant coronary disease,” Neha Pagidipati of the Duke Clinical Research Institute wrote in a companion editorial, referring to myocardial infarction, or heart attack. “However, the prevalence of CVD without traditional risk factors may be significantly lower than previously described.”
  • MedPage Today adds,
    • “The increase in early-onset cancers is not necessarily due to a rise in clinically meaningful cancers, researchers argued, but may be due to increased diagnostic scrutiny and overdiagnosis.
    • “Of the eight fastest-rising cancers, only two — colorectal and endometrial cancer — have shown a slight increase in early-onset mortality.
    • “For the six other cancers, stable or declining mortality rates alongside rising diagnoses suggest that greater detection (rather than more disease) may account for the trend.”
  • Per Health Day,
    • “Acute cystitis may signal the presence of urogenital cancers in middle-aged adults, according to a study published online Sept. 16 in BMJ Public Health.
    • “Filip Jansåker, M.D., Ph.D., from Lund University in Sweden, and colleagues examined the subsequent risks for urogenital cancers in men and women aged 50 years and older diagnosed with acute cystitis. The analysis included roughly 1.67 million men and 1.89 million women, including 177,736 men and 427,821 women diagnosed with acute cystitis (first event) from 1997 to 2018.” * * *
    • “It is plausible that urogenital cancer, and perhaps even precancerous changes in the urogenital organ, might increase the risk of cystitis because of compromised urinary tract and host defense,” the authors write.”
  • Genetic Engineering and Biotechnology News relates
    • “Bispecific antibodies and chimeric antigen receptor (CAR) T cells demonstrate potent cancer immunotherapy in clinical use, yet most cancers remain poorly targetable. High-affinity antibodies needed to maximize cancer killing also detect low antigen expression in normal tissue, which causes toxicity in healthy tissue. Identifying cancer-restricted cell-surface protein antigens remains an ongoing challenge. 
    • “In a new study published in Cell titled, “Safe immunosuppression-resistant pan-cancer immunotherapeutics by velcro-like density-dependent targeting of tumor-associated carbohydrate antigens,” researchers from the University of California (UC), Irvine, have reported that targeting cancer-associated glycans with binding proteins can trigger tumor cell death without toxicity to surrounding tissue. The biologically engineered immunotherapies, known as glycan-dependent T cell recruiter (GlyTR) compounds, were shown to be safe and effective in models for a spectrum of cancers, including breast, colon, lung, ovaries, pancreas and prostate. 
    • “It’s the holy grail—one treatment to kill virtually all cancers,” said Michael Demetriou, MD, PhD, a professor of neurology, microbiology and molecular genetics at the UC Irvine School of Medicine and corresponding author of the study. “GlyTR’s velcro-like sugar-binding technology addresses the two major issues limiting current cancer immunotherapies: distinguishing cancer from normal tissue and cancer’s ability to suppress the immune system.”

From the healthcare business front,

  • STAT News reports,
    • “Perimenopause is the new buzzword in the business of women’s health.
    • “The menopause market has proved so successful that companies are increasingly pushing products aimed at younger women too.”
  • Beckers Hospital Review breaks down the massive 138-hosptial Common Spirit health system’s revenue by region for the fiscal year ending June 30 in 2025 and 2024.
  • MedPage Today points out,
    • “Among more than 3 million Medicare Advantage enrollees, value-based payment models outperformed fee-for-service models for all 15 clinical quality outcomes.
    • ‘The mean score differences for blood glucose control and blood pressure control indicated “markedly better performance” with value-based payment models.
    • “Clinical quality performance consistently improved as financial arrangements moved toward 2-sided risk sharing.”
  • The Brown & Brown consulting firm discusses “Practical Approaches for Employers to Manage High-Cost Claimants in Health Plans.”
    • “Managing high-cost claimants requires a delicate balance of cost control, care quality and employee experience. Employers who invest in data-driven decision making, proactive care management and thoughtful plan design are best positioned to reduce the financial impact of high-cost claimants without sacrificing the well-being of their workforce.
    • “By taking a strategic and holistic approach, employers can turn a major cost challenge into an opportunity to enhance healthcare delivery, improve outcomes and foster a healthier, more productive employee population.”
  • The Institute for Clinical and Economic Review (ICER) announced,
    • “today that it will assess the comparative clinical effectiveness and value of Comirnaty® (Pfizer, BioNTech), Spikevax® (Moderna), mNexspike® (Moderna), and Nuvaxovid® (Novavax) for the prevention of COVID-19, including both the short- and long-term effects of the infection.
    • “The assessment will be publicly discussed during a meeting of the New England CEPAC in June 2026, where the independent evidence review panel will deliberate and vote on evidence presented in ICER’s report.
    • “ICER’s website provides timelines of key posting dates and public comment periods for this assessment.”
  • The Wall Street Journal reports,
    • “Novartis NOVN said it is launching a direct-to-patient platform in the U.S. to sell a discounted version of its Cosentyx drug, the latest big pharma company to move to cut prices ahead of the Trump administration’s deadline.
    • “The Swiss pharmaceutical company said Monday that it would offer select units of Cosentyx—a drug treating immune-mediated inflammatory conditions like psoriasis and psoriatic arthritis—at a 55% discount to cash-paying patients with a prescription. The platform will come into effect on Nov. 1.
    • “Novartis’s launch of a direct-to-patient platform and the discount comes after President Trump said in a letter to pharmaceutical companies in July setting a deadline of Sept. 29 to impose cuts on drug prices.”
  • Fierce Pharma adds,
    • “As pharma companies face an imminent deadline from President Donald Trump related to his “Most Favored Nation” (MFN) drug pricing demands, the industry’s top U.S. lobbying group is touting three “major actions” by its members and calling for some policy shifts of its own.
    • “The timing of the Sept. 29 press release by the Pharmaceutical Research and Manufacturers of America (PhRMA) coincides with the deadline set by the president when he laid out the steps pharma companies “must take” to align certain U.S. prices with lower prices overseas. 
    • “But rather than directly addressing the core component of Trump’s demand, the PhRMA communication centers on its members’ infrastructure spending, patient financial assistance programs and a new website designed to compile drugmakers’ direct sales offerings.
    • “PhRMA members are planning $500 billion in U.S. investments over the next 10 years, including $100 billion in projects that haven’t been announced yet, PhRMA CEO Steve Ubl wrote in an accompanying Washington Post op-ed piece Monday.
    • “Besides the capital projects, the industry trade group also plans to launch a website compiling its members’ direct sales offerings. Over the last several months, Big Pharma players have been rolling out new direct-to-patient sales platforms that offer cash-paying patients steep discounts to list prices for certain medicines. This is one component of the president’s push to rein in U.S. prices, and pharmaceutical companies are happy to stick it to middlemen in the U.S. whenever possible.”
  • Per BioPharma Dive,
    • “Antibody drug specialist Genmab on Monday agreed to acquire Dutch biotechnology company Merus in an $8 billion deal centered around a drug that’s shown potential treating head and neck cancer.
    • “Per deal terms, Genmab will pay $97 per share in cash to acquire Merus, representing a 41% premium to the biotech’s closing price on Friday of about $68.  
    • “The deal hands Genmab a drug called petosemtamab and that’s in late-stage testing for head and neck cancer. Phase 2 data presented at the American Society of Clinical Oncology meeting in May showed that the drug helped extend survival when used alongside Merck & Co.’s immunotherapy Keytruda, a result that boosted shares and suggested it could change care for those tumors.”
  • and
    • “Emma Walmsley, the first woman to lead a big pharma company as CEO, will step down from that post Dec. 31, handing the reins of one of Britain’s premier drugmakers to commercial chief Luke Miels.
    • “In a statement Monday, GSK said Walmsley, who has been running GSK since 2017, will depart as part of a succession plan. Miels’ selection was the outcome of a “rigorous process” conducted over the last few months and that included consideration of “internal and external candidates.” He’ll start serving as GSK’s full-time CEO on Jan. 1.
    • “The CEO change ends a nine-year run for Walmsley atop GSK. During that time, Walmsley steered the big drugmaker through a turbulent period, during which it spun out its consumer health business to focus on innovative drugs while facing persistent investor pressure to boost its productivity and growth prospects.
    • “GSK also deepened its investment in oncology, expanded its HIV drug portfolio and brought to market the first vaccine for respiratory syncytial virus.
    • “Yet GSK missed an opportunity during the COVID-19 pandemic, when it decided against developing its own vaccine and partnerships with Sanofi and CureVac hit setbacks and delays.” * * *
    • ‘Miels joined GSK in 2017 after stints at AstraZeneca, Roche and Sanofi, in positions in Europe, Asia and the U.S. He will be paid a base salary of nearly 1.4 million pounds and qualify for bonuses of up to 300%, in addition to other incentives and benefits, according to GSK’s statement.
    • “Walmsley, meanwhile, will also step down from GSK’s board effective Dec. 31, but will remain with the company through Sept. 30, 2026, to support Miels “given the potential impact to GSK’s operating environment arising from geopolitics and new technologies.”

Weekend Report

David Ermer–CDC, CMS, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, OPM, SCOTUS, U.S. Healthcare–

From Washington, DC,

  • Roll Call reports,
    • “The top four congressional leaders will head to the White House on Monday for a meeting with President Donald Trump in a last-ditch effort to prevent a partial government shutdown.
    • “The meeting, confirmed by sources familiar with the plans, comes after the president scrapped a separate discussion planned with just the two Democratic leaders.” * * *
    • “The Senate is back in session on Monday with 48 hours until agencies would have to start shutting down Oct. 1. The House, which on Sept. 19 passed a partisan GOP-drafted stopgap funding bill that would keep the government operating for seven weeks until the Thanksgiving recess, isn’t planning to return until at least Oct. 7.
    • “Speaker Mike Johnson wrote Friday on X that House Republicans “have done our job” and now it’s the Senate’s turn to act.” 
  • Here is link to the Congressional committee schedule for this week.
  • Roll Call notes,
    • “The Senate does have another option in the queue aside from leadership-driven proposals [for a continuing resolution], with a procedural vote expected Monday on a bill from Sen. Ron Johnson, R-Wis., to provide for automatic two-week continuing resolutions.
    • “My new bill simply provides for automatic two-week rolling continuing resolutions for any department for which an appropriation bill or longer-term continuing resolution hasn’t been passed. This would keep spending flat by prorating the previous year’s spending level,” Johnson wrote in a Sept. 21 Wall Street Journal opinion piece.”
  • SCOTUSblog informs us,
    • “Edward Lazarus, a former clerk to the late Justice Harry Blackmun, called it a “single marathon session.” Gregory Garre, who served as the U.S. solicitor general during the George W. Bush administration, described it as the place “where petitions go to die.” Lazarus and Garre were both referring to the “long conference” – a private meeting, taking place this year on Sept. 29, at which the justices will consider the roughly 2,000 petitions for review that have built up since their last regularly scheduled conference (on June 26) before their summer recess.
    • “The long conference is the unofficial start to the court’s new term, which by law officially begins on the first Monday in October. The tradition of a “long conference” at the end of September or in early October, before the justices take the bench to hear oral arguments, dates back to the early 1970s, according to a book by the late Chief Justice William Rehnquist. Until then, the court held its long conference during the first week in October and had oral arguments thereafter. But Blackmun suggested that the court should move its meeting to the last week in September, allowing it to begin oral arguments on the first Monday in October instead.”
  • Modern Healthcare lets us know,
    • “Medicare Advantage enrollment could slip next year, the Centers for Medicare and Medicaid Services announced Friday.
    • “Health insurance companies project Medicare Advantage membership will fall from 34.9 million this year to 34 million in 2026, CMS said in a news release. 
    • “That would mark the first annual decline in Medicare Advantage enrollment since at least 2007, according to CMS data analyzed by the health policy research organization KFF. The annual enrollment period runs Oct. 15-Dec. 7.
    • “Insurers also predict that Medicare Advantage will lose ground to fee-for-service Medicare next year. The privatized program surpassed traditional Medicare in 2023 but will cover 48% of beneficiaries in 2026, down from 50% this year, according to industry estimates reported to CMS.
    • “CMS offered a rosier assessment. “Based on recent historical experience and enrollment trends, CMS anticipates that enrollment in [Medicare Advantage] in 2026 will be more robust than the plans’ projections and that enrollment will be stable,” the agency said in the news release.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has granted de novo classification to a continuous glucose monitor made by Biolinq for people with Type 2 diabetes.
    • “Biolinq says its device is the first CGM that does not require a needle to place the sensor beneath the skin, instead using a microsensor array that sits less deep in the skin.
    • “People with diabetes have a growing number of CGM options as the FDA has authorized new sensors in recent years, including the first over-the-counter sensors and implanted CGMs that can be worn for one year.“
  • P.S. The OPM Director did not add a new post to his Secrets of OPM blog on Friday.

From the public health and medical / Rx research front,

  • Healio tells us,
    • “A federal law required all new cars to be equipped with backup cameras after May 2018.
    • “The mandate was associated with a 62% reduction in back over injuries in a trauma center in Houston.”
  • and
    • “COVID-19 vaccination during pregnancy provides significant protection for mothers and their babies with no associated increase in risk, according to data from more than 1.2 million pregnancies presented at the AAP’s annual meeting.
    • “COVID-19 vaccination reduced admission, mortality and pregnancy-specific complications,” Nikan Zargarzadeh, MD, a postdoctoral research fellow in the division of fetal medicine and surgery at Boston Children’s Hospital, told reporters on Saturday. “On the neonatal side, it reduced NICU admission.”
  • and
    • “Many women suffer complications in the time between giving birth and the 6-week visit.
    • “A Women in Medicine Summit presenter discussed how her own journey informs her work and what she is doing to help new moms.”
  • NPR Shots reports,
    • “For more than four years, Lynn Milam’s life was bound by the pain that radiated from her swollen joints.
    • “My children could not hug me,” she says. “I couldn’t hold my husband’s hand.”
    • “Milam also couldn’t climb stairs or help raise her teenage son. She spent most days on the couch.
    • “The reason was rheumatoid arthritis, which occurs when the immune system starts attacking the lining of joints.
    • “Milam tried everything: physical therapy, acupuncture, steroids and even the latest immune drugs. Nothing worked.
    • “That changed in October of 2023, when a surgeon implanted an experimental device in Milam’s neck. For a minute each morning, it delivers pulses of electricity to her vagus nerve, which connects the brain with internal organs.
    • “Three weeks in, my elbow pain was completely gone,” she says. “Then my hands didn’t hurt anymore, the swelling started going away.”
    • “Eventually, all symptoms of rheumatoid arthritis had vanished. Milam, 60, says she and her husband have regained the life they enjoyed before she got sick.”
  • Per Medscape,
    •  “Tirzepatide was associated with improvements in body weight and body composition, and with lower insulin doses, in the first-ever randomized controlled trial (RCT) of the drug in people with type 1 diabetes (T1D).
    • “Tirzepatide may play a role in weight management in adults with T1D and obesity, even at low doses,” Jennifer R. Snaith, MD, of the Garvan Institute of Medical Research and St. Vincent’s Hospital Sydney, both in Darlinghurst, Australia, said at European Association for the Study of Diabetes (EASD) 2025 Annual Meeting.” * * *
    • [A]sked to comment, independent industry consultant Charles Alexander, MD, noted that, while the data look good, it’s a small study and that Lilly’s two much larger ongoing phase 3 trials of tirzepatide in T1D, SURPASS-T1D-1 (NCT06914895), and SURPASS-T1D-2 (NCT06962280), aimed at obtaining FDA approval, will produce more definitive results.
    • Alexander also pointed out that Novo Nordisk is not conducting a similar RCT of semaglutide in T1D. “At the end of the day,” if it’s approved, “all you’re going to have [in terms of incretin drugs] is tirzepatide licensed for T1D.” 
    • Snaith’s team is also conducting a further study, TIRTLE2, with insulin resistance as the primary outcome.

From the U.S. healthcare business front,

  • HR Dive reports,
    • “Amid rising healthcare costs, Amazon announced benefit updates Sept. 17 that include a “reduced-cost” healthcare plan for its fulfillment and transportation employees. Workers on the plan will only need to pay $5 a week and $5 for copays starting in 2026.
    • “Those costs amount to about $22 per month or $260 per year for employees. This results in reductions of weekly contributions by workers by 34% and copays for primary care, mental health and nonspecialist visits by 87%, Amazon said.
    • “The changes were made based on feedback offered by workers, Udit Madan, senior vice president of Amazon Worldwide Operations, said in the announcement.”
  • Fierce Pharma notes,
    • “Serial entrepreneur Robert Wessman, who has had a golden touch creating, acquiring and spinning off companies that primarily sell generic drugs, has brought together two of his fastest-growing enterprises as Lotus Pharmaceuticals has acquired a 100% equity stake in [U.S. based] Alvogen.
    • “The move, which transforms Alvogen into a subsidiary, catapults Taiwan-based Lotus into a top-20 specialty pharmaceutical company worldwide, according to a release. The deal has a total value of up to $2 billion.
    • The deal could also help shield Lotus—which does most of its business in Asia—from U.S. tariffs on pharmaceutical products. Thursday night, in a post on social media, President Donald Trump wrote that starting Oct. 1, the U.S. would impose a 100% levy on drugs imported by companies that aren’t in the process of building U.S. facilities.
    • “The transaction gives Lotus “access to U.S. R&D, manufacturing and commercial capabilities alongside our established strengths in Asia,” the company said in a release.”

Thursday report

David Ermer–CMS, Congress, FDA, Generative AI, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports,
    • “The U.S. government is hurtling toward a shutdown in a matter of days with no exit ramp in sight, as Republicans and Democrats latch onto starkly different positions and the White House threatens to lay off more federal workers.
    • “Republicans are seeking a seven-week extension in federal funding at current levels, and they have dismissed Democrats’ demands for hundreds of billions of dollars in healthcare spending. In a move to raise the political pressure, President Trump’s budget chief late Wednesday vowed to use any lapse in funding to make deeper cuts in the federal workforce, a threat Democrats rejected as blackmail.
    • “Democrats see the funding deadline as a rare opportunity to shape legislation, and the party’s base voters are desperate for elected representatives to show more fight after months of demoralizing political defeats. Republicans are loath to offer any concessions, putting both parties on a collision course ahead of the Oct. 1 deadline.
    • “Democrats have “asked us to do something that’s totally unreasonable,” President Trump told reporters on Thursday. Asked about the possibility of a shutdown, he said: “Could be. Because the Democrats are crazed. They don’t know what they are doing.”
    • “Senate Minority Leader Chuck Schumer (D., N.Y.) has said he plans to stand firm this time and demand bipartisan talks, rather than acquiesce to a Republican plan to keep the government open, like he did in March. He said Democrats won’t be intimidated by the latest threat of federal layoffs.
    • “This is one of their threats, and their threats are not going to succeed,” Schumer said in an interview. “A lot of my colleagues who I’ve talked to today are very angry about this.”
  • Per Roll Call,
    • “Sources on both sides of the aisle and nonpartisan analysts agreed that, beyond the tough talk, top congressional Democrats have a weak hand to play and no discernible strategy for extracting the concessions from President Donald Trump and GOP leaders that they want on health care policy.
    • “A shutdown for the sake of a shutdown doesn’t help anyone,” a former Democratic congressional aide granted anonymity to speak candidly said. “If there is a shutdown, there also needs to be a plan to get out of it — and it will require a deal on all sides to end it, at a time when tensions would be even higher. It’s hard to turn back to bipartisan negotiations after that.”
  • Federal News Network adds,
    • “The Trump administration is taking a more aggressive approach than usual to what would happen in a government shutdown, after a White House memo Wednesday night told agencies to plan for further reductions in force if government funding lapses early next week.
    • “But with just days left before a government shutdown, many are questioning the ability for agencies to put together further RIF plans at all, since the reduction-in-force process is typically complicated and time-consuming, often taking months or longer.”
  • Bloomberg reports,
    • “The US will impose a 100% tariff on branded or patented pharmaceuticals, President Donald Trump announced Thursday.
    • “Starting October 1st, 2025, we will be imposing a 100% Tariff on any branded or patented Pharmaceutical Product, unless a Company IS BUILDING their Pharmaceutical Manufacturing Plant in America,” Trump said in a social media post.
    • “Trump said there would be no tariffs on pharmaceutical products if companies have broken ground on a US manufacturing plant, or if such a plant is under construction.”
  • and
    • “Pharmacy middlemen are working on a proposal to voluntarily change some of their business practices to avoid new regulation from the Trump administration.
    • “The proposals under discussion include ensuring patients don’t pay more than a pharmacy would charge to someone without insurance and increasing the use of lower-cost versions of expensive biologic drugs.
    • “The Pharmaceutical Care Management Association has drafted proposals to bring to the Centers for Medicare and Medicaid Services, according to a document viewed by Bloomberg News.”
  • The American Medical Association adds,
    • “The Department of Commerce Sept. 24 released a notice seeking public comment on an investigation it launched Sept. 2 on imports of personal protective equipment, medical consumables and medical equipment under Section 232 of the Trade Expansion Act of 1962. The provision authorizes the president to impose tariffs or other trade restrictions if an investigation determines that the importation of particular goods affects national security. The department is seeking comment on a range of criteria, including the current and projected demand for PPE, medical consumables and medical equipment; the extent to which production can meet demand; the role of foreign supply chains in meeting U.S. demand; the concentration of U.S. imports of those products and more. Comments are being accepted for 21 days following publication in the Sept. 26 Federal Register.”
  • Bloomberg tops it off with this,
    • “Three hours inland from Chennai, India, traffic crawls on a half-finished road past rice fields and cow crossings until it reaches a newer complex of neat white buildings. Among them is the cancer wing of a hospital founded over a century ago by American missionaries.
    • “By morning, the line of people waiting to be seen at Christian Medical College Vellore’s Ranipet Campus snakes from the parking lot to the front door. In a basement treatment room one day in May, several of those who’ve made it inside sit in beds getting an intravenous drip of a Bristol Myers Squibb Co. drug called Opdivo or a competing Merck & Co. drug, Keytruda. A single infusion might cost at least $7,000 at the standard dose in the US, and a year’s treatment more than $200,000. Here, by financial necessity, most of the patients are getting as little as one-sixth of that.  
    • “The remarkable thing is that the radically low doses may also be effective at keeping cancer sufferers alive, doctors here and in other hospitals across India say. The science isn’t settled, but hospitals in Israel, France, the Netherlands, Canada and the UK are all testing or implementing more modest dose reductions. A small trial in the US also found some benefits. The consequences could be dramatic, expanding access to cancer treatment in poor countries and bending the curve of skyrocketing drug prices in the developed world. Smaller doses could also help limit the serious side effects many patients endure, from diarrhea to thyroid problems.
    • “A broad reevaluation of dosing has the potential to benefit hundreds of thousands of people in developing countries who otherwise wouldn’t be able to afford the drugs. One obstacle has stood in the way: the drugmakers themselves. Paid per dose, they stand to lose billions of dollars if doctors prescribe less medicine to their patients.”
  • From ARPA-H news releases
    • The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new research and development opportunity through its Treating Hereditary Rare Diseases with In Vivo Precision Genetic Medicines (THRIVE) program. THRIVE intends to develop integrated platform technologies to accelerate precision genetic medicines (PGMs) and provide single-intervention precision treatments to slow, reverse, or prevent diseases at the genetic level. The program is designed to optimize affordability, scalability, and sustainability of lifesaving PGMs for patients through existing regional treatment centers and virtual clinics. This will allow patients to be seen and treated where they live.” * * *
    • “Learn more about THRIVE on its program page, including information about the solicitation and Proposers’ Day.” 
  • and
    • “The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS), today announced a new funding opportunity through its Genetic Medicines and Individualized Manufacturing for Everyone (GIVE) program. With cutting-edge production technologies, the program seeks to establish the U.S. as a frontrunner in advanced manufacturing methods for high-quality genetic medicines.” * * *
    • “Learn more about GIVE on its program page, including information about the ISO solicitation and Proposers’ Day registration.”
  • Per a U.S. Office of Personnel Management news release,
    • The U.S. Office of Personnel Management (OPM) today announced record levels of engagement and leadership from the Chief Human Capital Officers Council (CHCOC) under the Trump Administration, underscoring the Council’s critical role in driving forward personnel policy and workforce reform across the federal government. The Chief Human Capital Officers Council is the principal interagency forum for federal human capital leaders, bringing together the Chief Human Capital Officers from across the Executive Branch to coordinate policy, share best practices, and advance government-wide workforce initiatives.
    • Since January of this year, the Council has held 71 sessions, an increase of almost double compared to the 40 sessions held last year. These sessions cover everything from discussing the Deferred Resignation Program and return-to-office policies to SES performance and collective bargaining. Between January and March alone, the Council convened 34 times in just 50 workdays. Alongside these sessions, the Council has distributed more than 200 communications to federal agencies this fiscal year, including official memos, weekly updates, and special notices.
  • OPM also recently posted Benefits Administration Letter 25-102 about FEHB Enrollment Coordination for Married Federal Employees and Annuitants.
  • Avalere Health discusses an upcoming meeting at which new ICD-10 codes for 2026 will be selected.

From the Food and Drug Administration front,

  • BioPharma Dive relates,
    • “Capricor Therapeutics executives came out of a meeting with Food and Drug Administration officials confident that they can reverse a rejection of their experimental cell therapy for Duchenne muscular dystrophy. 
    • “The FDA turned down Capricor’s application for the drug, deramiocel, in July after questioning the research supporting its effectiveness. At the time, Capricor CEO Linda Marbán said the rejection was a surprise and that no major issues had been raised during the review.
    • “Now, FDA officials are indicating that they will reconsider the application with new data from a clinical trial called Hope-3 that’s already been completed, Capricor said Thursday. That’s important because Capricor won’t have to start all over with a new submission. “This is a giant win for us,” Marbán said during a conference call with analysts. Initial trial results are expected in the middle of the fourth quarter.”
  • and
    • “The Food and Drug Administration on Thursday approved a new medicine for breast cancer, clearing Eli Lilly’s Inluriyo for people with a specific genetic mutation.
    • “Previously known as imlunestrant, the drug has been cleared for use in a subgroup of adults whose metastatic, estrogen receptor-positive, HER2-negative breast cancer has progressed after at least one hormone therapy. The approval makes the treatment available specifically to people who fit that criteria and have mutations to a gene called ESR1 — an alteration Lilly believes to occur in about half of people with that form of the disease either during, or after, exposure to hormone therapy.
    • “The clearance was based on results published in the New England Journal of Medicine last year. Those findings, from a study called EMBER-3, showed that Inluriyo helped reduced the risk of disease progression or death among those with ESR1 mutations by 38% when compared to standard hormone-suppressing therapies. Inluriyo delayed tumor progression by a median of 5.5 months, or close to 2 months longer than those on typical drugs.”  
  • and
    • “Heartflow has received 510(k) clearance for an updated version of its plaque analysis algorithm, the company said Monday.
    • “The updated algorithm shows a 21% improvement in plaque detection, compared to the original version of the technology, the company said. 
    • “Heartflow disclosed the clearance alongside news that Cigna has become the second national insurer after UnitedHealthcare to update its policies to cover the plaque analysis product.”
  • MedPage Today points out,
    • “A risk evaluation and mitigation strategies (REMS) program is no longer required for the thyroid cancer therapy vandetanib (Caprelsa), the FDA announced on Thursday.
    • “The agency had required the safety program for vandetanib to ensure appropriate heart rhythm monitoring and safe use since its approval in 2011opens in a new tab or window as treatment for medullary thyroid cancer in patients whose disease has spread or cannot be surgically removed.
    • The approval of vandetanib was based on results from the phase III randomized ZETA trial in which patients randomized to receive vandetanib experienced a 65% reduction in the risk of disease progression compared to patients on placebo. A REMS was required for vandetanib due to potential for QT prolongation and reported cases of torsades de pointes and sudden death in patients taking the drug.
  • Fierce Pharma informs us,
    • “After nearly two decades in the endocrine scene, Crinetics is making its commercial debut with the approval of a game-changing treatment for the rare growth disorder acromegaly.
    • “The FDA on Thursday signed off on Crinetics’ paltusotine—now christened Palsonify—as a first-line treatment for adults with acromegaly for whom surgery didn’t work or isn’t an option.
    • “The drug is a selectively targeted somatostatin receptor type 2 (SST2) agonist. Unlike other somatostatin drugs that make up the bulk of current acromegaly care options, Palsonify is a small molecule, non-peptide therapy that can be taken orally, freeing up patients from frequent and often painful injections.
    • “The treatment marks the “next level of care for patients with acromegaly,” Scott Struthers, Ph.D., co-founder and CEO of Crinetics, said in a recent interview with Fierce Pharma, staking that claim on the drug’s ability to both help control patients’ hormone levels and address their symptoms in a once-daily treatment option.”
  • Per FDA news release,
    • “Today, the U.S. Food and Drug Administration authorized marketing of the Essilor Stellest eyeglass lenses to correct myopia, commonly referred to as nearsightedness, with or without astigmatism and to slow the progression of the disease in children 6 to 12 years old at the initiation of treatment.”

From the judicial front,

  • Modern Healthcare reports,
    • “A federal court has tossed a rule outlining how auditors must review Medicare Advantage insurance companies for overpayments, adding uncertainty to the federal government’s plan to audit every plan annually.
    • “On Thursday, Judge Reed O’Connor, of the U.S. District Court for the Northern District of Texas in Fort Worth, vacated the 2023 Medicare Risk Adjustment Data Validation, or RADV, rule, on the grounds that regulators violated the Administrative Procedure Act of 1946.”
    • “Under the rule, which was finalized in January 2023, the Centers for Medicare and Medicaid Services eliminated a key statistical tool, the fee-for-service adjuster, used to compare error rates in traditional Medicare versus Medicare Advantage. Regulators planned to apply the new audit method retroactively to insurers’ risk-adjustment code reviews dating back to 2018. When the rule was finalized, CMS estimated that the more stringent reviews would result in insurers returning $4.7 billion to the agency between 2023 and 2032. 
    • “Humana sued over the rule in September 2023, alleging the new audit methodology held private Medicare insurers to a higher standard than the fee-for-service program. 
    • “O’Connor sided with the insurer.  In a Thursday order, he ruled that CMS failed to adequately notify the industry that actuarial equivalence between traditional and Medicare Advantage plans no longer applied.
    • “Because there was no meaningful notice of defendants’ ultimate finding that actuarial equivalence does not apply to RADV audits, there was no meaningful dialogue regarding the costs and benefits of the surprise changes,” O’Connor wrote in the order.” 

From the public health and medical / Rx research front,

  • MedPage Today lets us know,
    • “Women who missed their first screening mammogram had a 53% higher risk of stage III breast cancer over the next 25 years and almost a fourfold higher risk of stage IV breast cancer.
    • “Breast cancer mortality was 40% higher among screening nonparticipants.
    • “Breast cancer incidence was nearly identical, suggesting the increased risk of later-stage diagnosis and breast cancer mortality resulted from delayed detection.”
  • Per Health Day,
    • “During August 2021 to August 2023, only 36.4 percent of U.S. adults had no cardiovascular disease (CVD) risk factors, according to a September data brief published by the National Center for Health Statistics.
    • “Catharine A. Couch, Ph.D., R.D., from the National Center for Health Statistics in Baltimore, and colleagues presented prevalence estimates for none, one, or two or more CVD risk factors (uncontrolled high blood pressure, uncontrolled high blood lipids, uncontrolled high mean blood glucose, and high body mass index) in U.S. adults from August 2021 to August 2023.
    • “The researchers found that 36.4, 34.9, and 28.7 percent of U.S. adults had no, one, and two or more CVD risk factors, respectively. More men than women had two or more CVD risk factors (31.7 versus 25.8 percent). With age, there was a decrease in the percentage of adults with no CVD risk factors, while a higher percentage of older adults had one or two or more CVD risk factors. Those with family income 350 percent or more of the federal poverty level had the highest percentage of adults with no CVD risk factors and the lowest percentage with two or more CVD risk factors. The percentage of adults with two or more CVD risk factors increased from 2013 to 2014 to August 2021 to August 2023.”
  • and
    • “Physical frailty may contribute to the development of dementia, according to a study published online Sept. 17 in Neurology.
    • “Xiangying Suo, from the School of Public Health of Zhengzhou University in China, and colleagues conducted a prospective cohort study based on U.K. Biobank participants without dementia to examine the link between physical frailty and dementia. Five criteria were used to define physical frailty (weight loss, exhaustion, physical inactivity, slow walking speed, and low grip strength).
    • “A total of 8,900 dementia cases were documented during a median follow-up of 13.58 years among 489,573 participants. The researchers found that the risk for dementia was significantly higher in those with prefrailty and frailty compared with nonfrail individuals (hazard ratios, 1.50 and 2.82, respectively). Compared with those with low genetic risk and nonfrailty, the highest risk for dementia was seen for participants with frailty and high genetic risk (hazard ratio, 3.87 for high polygenic risk score; 8.45 for APOE-ε carriers). A potential causal relationship was seen between physical frailty and dementia in the forward Mendelian randomization (MR) analysis (odds ratio, 1.79), while a null causal association was suggested in the reverse MR. Potential underlying mechanisms linking physical frailty to dementia include genetic background and neurologic and immunometabolic function.”
  • BioPharma Dive considers “Cancer patients are living longer than ever. Pain drugmakers haven’t kept up. Decades of slow-moving research, along with broader failures of the healthcare system, have left millions of people in daily pain. Doctors fear that’s bound to continue.”
  • BioPharma Dive also notes,
    • “Eli Lilly has canceled one clinical trial of an experimental muscle-sparing obesity drug, citing “strategic business reasons,” according to a federal database. The study was one of two Phase 2 trials testing the drug, known as bimagrumab, alone or with Lilly’s marketed medicine in people with obesity. The now-halted study included Type 2 diabetics as well.
    • “In an email to BioPharma Dive, a Lilly spokesperson said company executives “routinely evaluate our clinical development programs to optimize the potential for each product” and noted that a separate trial involving non-diabetic people with obesity is still underway. The trial stoppage was first reported by Bloomberg.
    • “Bimagrumab is among the drugs designed to preserve muscle in people taking weight loss drugs like Zepbound and Novo Nordisk’s Wegovy, which can cut lean mass as well as fat. But at least one biotech has said that additive weight loss effects are an approval requirement, suggesting higher clearance standards have been established by the Food and Drug Administration.”
  • The Washington Post explains why the brain hangs on to some memories but allows others to fade. Tying “fragile” memories to emotional events could help people remember them better in the future, researchers at Boston University believe.”
  • Per a National Institutes of Health news release,
    • “Today, the National Institutes of Health (NIH) announced the award of contracts for launching the Standardized Organoid Modeling (SOM) Center, a national resource that will be dedicated to using cutting-edge technologies to develop standardized organoid-based new approach methodologies (NAMs) that deliver robust, reproducible, and patient-centered research findings. With contracts totaling $87 million for the first three years, the center will be housed at the Frederick National Laboratory for Cancer Research (FNLCR), a facility supported by NIH’s National Cancer Institute (NCI). The center’s goal will be to leverage the latest technologies to enable real-time optimization of organoid protocols.
    • “This groundbreaking initiative will transform how we conduct biomedical research through innovative approaches to advancing human-based technologies,” said NIH Director Dr. Jay Bhattacharya. “By creating standardized, reproduceable, and accessible organoid models, we will accelerate drug discovery and translational science, offering more precise tools for disease modeling, public health protection, and reducing reliance on animal models.”

From the AI front,

  • STAT New reports,
    • “Artificial intelligence may help radiologists spot disease, but throwing the technology at millions of CT scans or mammograms is not without risks to patients and may drive up costs without showing much benefit. Katie Palmer reports on two efforts to prove out the potential.
    • “A large randomized controlled trial will explore the value of AI-aided mammography in screening for breast cancer. The technology is already widely used in the U.S., but the best evidence that it’s useful comes from Europe. The $16 million trial is funded by the Patient-Centered Outcomes Research Institute. Read more on what researchers may find here.
    • “Next month, NYU Langone Health will begin checking bone density in CT scans of people over 65 for osteoporosis, a condition that often goes undetected until someone breaks a bone. The health system may expand the work if it’s proven to help. This kind of opportunistic screening, which repurposes otherwise acquired scans, could be used to identify many treatable conditions. Katie’s interview is worth a read.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “CommonSpirit Health closed another fiscal year with operations in the red, with the large Catholic nonprofit pointing to expenses growth outpacing revenues “despite strong volume, salary cost management and higher productivity.”
    • “The 138-hospital system reported an as-recorded operating loss of $687 million (-1.8% operating margin) for the fiscal year ended June 30, 2025, as compared to the prior year’s $581 million operating loss (-1.5% operating margin).
    • “However, after adjustments to normalize delayed income from the California Provider Fee Program, CommonSpirit somewhat improved its stature with a $225 million operating loss (-0.6% adjusted operating margin) as opposed to fiscal 2024’s $875 million operating loss (-2.4% adjusted operating margin).
    • “Net income in fiscal 2025 was $1.1 billion as recorded and nearly $1.6 billion as adjusted, both increases over the prior year’s respective $797 million and $503 million.”
  • and
    • “Value-based cancer care navigation company Thyme Care raised $97 million in series D funding backed by major strategic investors across payers, employers, health systems and retail health.
    • “The latest funding propels Thyme Care’s valuation to north of $1 billion, a 2x increase from its valuation in July 2024 when it raised $95 million, according to a company spokesperson.
    • “The company plans to use the new funding to expand its business across verticals and to take on more breaking points in the oncology journey that drive up costs and cause friction in the patient experience, Robin Shah, CEO and co-founder of Thyme Care, told Fierce Healthcare.
    • “Thyme Care is now focused on tackling treatment denials, high drug costs and “the barriers that delay or prevent access to timely, affordable and appropriate care,” Shah said.’
  • and
    • “Medicare Advantage (MA) has been a consistent earnings booster for insurers, but recent challenges in this space are likely to ding profitability, according to a new report.
    • “Analysts at AM Best found that elevated utilization trends beginning in 2023 led to a $5.7 billion underwriting loss in 2024 for MA plans, while insurers reported gains in the previous five years. Underwriting gains in MA accounted for 40% of total gains from 2019 to 2022, but that dropped to 20% in 2023.
    • “The report found that close to three-quarters of companies with a significant concentration in MA reported underwriting losses in 2024.
    • “Medicare Advantage enrollment and premium continue to grow as more people are aging into the program. However, plans have experienced an increase in utilization and medical trends that have persisted longer than expected,” said Jason Hopper, associate director for industry research and analysis at AM Best, in a press release.“
    • “Changes to the risk-adjustment payment model by the Centers for Medicare and Medicaid Services, as well as lower Star Ratings across the industry, also have contributed to recent underwriting losses,” Hopper said.
  • MedTech Dive informs us,
    • “Guardant Health and Quest Diagnostics will collaborate to offer Guardant’s Shield blood-based colorectal cancer test through Quest’s distribution network, the companies said Wednesday.
    • “Physicians will be able to order the test through their Quest accounts and electronic health record starting in the first quarter of 2026.
    • “In an investor day presentation, Guardant Co-CEO AmirAli Talasaz also revealed plans to expand Shield to include multi-cancer detection. The multi-cancer offering will be available nationally in October.”
  • Modern Healthcare reports,
    • “As more upstarts strive to make a splash in the pharmacy benefit manager sector, RxBenefits CEO Robert Gamble thinks his company has devised something truly novel.
    • “Like other companies seeking to disrupt a market dominated by CVS Health subsidiary CVS Caremark, UnitedHealth Group division Optum Rx and Cigna unit Express Scripts, Illuminate Rx promises pharmacy benefits without spread pricing or hidden fees, and with transparency and a focus on generic and biosimilar drugs. The company launched Illuminate Rx this month.
    • “What Gamble said differentiates this offering is that RxBenefits has added an in-house PBM to its marketplace platform, where self-funded employers, brokers and benefits consultants can select among Illuminate Rx and other PBMs for the best deals.”
    • “RxBenefits, which serves 3 million insurance members and manages $3 billion in annual pharmacy spending, named veteran executive Gamble as CEO last December following Wendy Barnes’ departure to become president and chief executive of the pharmaceutical discount vendor GoodRx.”

Weekend update

David Ermer–CDC, Congress, COVID-19 vaccine, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–
  • Congress is on a District/State work break this week.
  • Govexec tells us,
    • “Newly elected Rep. James Walkinshaw, D-Va., this week formally took over for his predecessor, the late Rep. Gerry Connolly, in leading advocacy for an array of bills aimed at improving the pay and civil service protections of federal workers.” * * *
    • “The House on Tuesday granted Walkinshaw’s unanimous consent request to become lead sponsor for four bills that Connolly had previously introduced, all relating to federal personnel policy.”
  • Plan Sponsor lets us know,
    • “The Senate confirmed Daniel Aronowitz as assistant secretary of labor for the Employee Benefits Security Administration on Thursday.
    • “EBSA is responsible for enforcement of the Employee Retirement Income Security Act and related laws and regulations, along with protecting employer-based retirement, health and welfare benefits for workers and retirees.
    • “During his June 5 confirmation hearing, the former president of Encore Fiduciary pledged to streamline retirement plan oversight and end the ‘war’ on employee stock ownership plans, also known as ESOPs.”
  • OPM typically announces the next year’s FEHB / PSHB government contributions in the second half of September. OPM shares this information with Congress before making the announcement which suggests that the announcement will be made next week when Congress returns to Capitol Hill.
  • Nextgov/FCW points out,
    • “The Office of Personnel Management is rolling out ChatGPT to its employees this week, its director told employees Tuesday. 
    • “This is part of our broader effort to equip you with AI tools that help you work faster, think bigger, and collaborate better,” the agency’s director, Scott Kupor, told staff in an email shared with Nextgov/FCW by the agency. 
    • “Employees already can access Microsoft 365 Copilot chat, the email says, but now they’ll have access to OpenAI’s ChatGPT-5, too. 
    • “AI is a great assistant, but you’re still the expert. I know some of you are excited, some are curious, and some are wary. In the coming weeks, [the Office of the Chief Information Officer] will host brown bag sessions to help clarify and ensure you get the most out of these tools,” the email reads. “Let’s lead the way in using AI thoughtfully and effectively — starting now.”

From the ACIP recommendations front,

  • The Pharmacy Times article offers more details about the Covid vaccination decisions made at the ACIP meetings last week. 
    • “The Advisory Committee on Immunization Practices (ACIP) has voted 12-0 to recommend COVID-19 vaccines be administered based on individual-based decision-making, also known as shared clinical decision making, for adults aged 65 and older, rather than a universal recommendation. 
    • “They voted to recommend the same language for individuals aged 6 months through 64 years, with an emphasis that risk-benefit for vaccination is most favorable for individuals at increased risk and lowest for individuals not at increased risk.1
    • “Another vote on the belief that state and local jurisdictions should require a prescription for the administration of a COVID-19 vaccine failed 6-6, with the chair, Martin Kulldorff, PhD, breaking a tie to ensure the vote’s failure.
  • The Covid vaccine is not the first time that ACIP recommended shared decision making. The ACIP website includes an FAQ on shared decision making. A pharmacist is a healthcare provider for purposes of shared decision making. 
  • From a maintaining the status quo standpoint, it’s very important that ACIP rejected a recommendation to require a prescription for Covid vaccines. 
  • The New York Times reports yesterday,
    • Before the C.D.C. panel voted, CVS and Walgreens, the nation’s two largest pharmacy chains, were requiring prescriptions in some states because of laws forbidding pharmacists to administer vaccines in the absence of a recommendation from the panel.
    • But if the head of the C.D.C. adopts the panel’s recommendations, CVS will start providing the shots without prescriptions nationwide, including to people outside the F.D.A.-approved groups, according to a CVS spokeswoman, Amy Thibault.
    • Walgreens did not immediately confirm what it would do.
  • ACIP’s website explains
    • “The Advisory Committee on Immunization Practices (ACIP) develops recommendations on how to use vaccines to control disease in the United States.
    • “These recommendations become official CDC policy once adopted by CDC’s Director.
    • “This page provides resources related to ACIP recommendations and lists recommendations from ACIP meetings that are pending publication in CDC’s Morbidity and Mortality Weekly Report (MMWR).”
  • An HHS news release on Friday states,
    • “I commend the committee for bringing overdue scientific debate on vaccination to the American people,” said Deputy Secretary of Health and Human Services and CDC Acting Director Jim O’Neill. A recommendation from ACIP becomes part of the CDC immunization schedule if it is adopted by the CDC director.”
  • The CDC director typically adopts ACIP recommendations promptly. The FEHBlog will keep an eye out.

From the Food and Drug Administration front,

  • The Wall Street Journal reports,
    • “The FDA, under President Trump’s directive, is cracking down on direct-to-consumer pharmaceutical ads.
    • “The FDA sent letters to drugmakers citing issues with ads that potentially violate drug-marketing laws.
    • “The FDA is scrutinizing ads that it says overhype drug effectiveness, not just those omitting side effects, marking a shift in enforcement.”
  • The Washington Post informs us,
    • “The Trump administration is expected to unveil new efforts on Monday exploring how one medication may be linked to autism and another one can treat it, according to four people with knowledge of the plans who spoke on the condition of anonymity because the announcement was not yet public.
    • “Federal health officials are expected to raise concerns about pregnant women’s use of acetaminophen, the active ingredient in Tylenol and one of the most widely used medications globally. Officials have been reviewing previous research — including an August review by Mount Sinai and Harvard researchers — that suggests a possible link between Tylenol use early on in pregnancy and an increased risk of autism in children. They plan to warn pregnant women against using Tylenol early on unless they have a fever, according to the four individuals.
    • “In addition, officials plan to tout a lesser-known drug called leucovorin as a potential autism treatment. Leucovorin is typically prescribed to counteract some medications’ side effects and to treat vitamin B9 deficiency. Early double-blind, placebo-controlled trials administering leucovorin to children with autism have shown what some scientists describe as remarkable improvements in their ability to speak and understand others. Officials at the Food and Drug Administration have recently been reviewing new language that could apply to the drug.”

From the public health front,

  • Per Medscape,
    • “Use of GLP-1 receptor agonists (GLP-1s) was associated with a reduction in fragility fractures among older women with type 2 diabetes (T2D) in a retrospective analysis of data from a global health network. The results suggest that GLP-1 therapy could contribute to bone health.”
  • Medscape also identifies benefits and risks to watch out for when older adults take GLP-1 drugs.
    • “In adults over 65, GLP-1 use has both potential benefits and risks for age-related health. Physicians should stay alert, monitor closely, and address side effects proactively.’
  • NPR notes,
    • “Doctors who perform skin cancer surgeries often recommend nicotinamide — which is a form of Vitamin B3 — to their patients. It’s been shown to protect cells from UV radiation damage.
    • “Now, a new study of nearly 34,000 veterans, finds this over-the-counter supplement is linked to a reduction in non-melanoma skin cancers among people who’ve already had skin cancer. The research was published in JAMA Dermatology.
    • “The biggest reduction was seen among people who began taking the supplement after being diagnosed with their first skin cancer. Researchers found those who took 500 mg of nicotinamide, also known as niacinamide, twice daily, for at least one month, had a 54% reduced risk of developing another skin cancer, compared to patients who did not take the supplement.”

Friday report

David Ermer–CDC, CMS, Congress, COVID-19, COVID-19 vaccine, FDA, Medical / Rx research, Medicare, NCQA, No Surprises Act, OPM, Patient safety, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports
    • “Senate Democrats blocked Republicans’ stopgap measure that would keep the government funded until late November and insisted that major healthcare spending be added to the bill, raising the odds for a partial shutdown in less than two weeks.
    • “Friday’s vote in the Republican-controlled Senate was 44 in favor and 48 against, short of the 60 votes required. Sens. Rand Paul of Kentucky and Lisa Murkowski of Alaska were the only Republicans to vote against the measure, while Democratic Sen. John Fetterman voted in favor. Several Republicans were absent. 
    • “The GOP-led House narrowly passed the measure earlier in the day in a 217-212 vote largely along party lines.
    • “The failure of the bill in the Senate set the stage for a down-to-the-wire standoff, with both parties standing firm and saying the other one would take the blame for a fall shutdown. * * *
    • Democrats proposed an alternative that would fund the government through Oct. 31 and reverse hundreds of billions of dollars in cuts to Medicaid enacted under the Republican tax-and-spending legislation that Republicans have rebranded the “working families tax cut.” The Democratic alternative would permanently extend certain ACA subsidies that expire at the end of this year. * * *
    • Republicans rejected the Democratic proposal as unserious. It failed in its own vote with 47 in favor and 45 opposed, short of the 60-vote requirement. Republicans control the Senate 53-47.
    • “The Democrats want a ransom payment of more than $1 trillion to keep the government open for only four more weeks,” said Senate Majority Whip John Barrasso (R., Wyo.).
    • [Senator Lisa] Murkowski [(R. AK), who voted against both the Republican plan and the Democratic proposal, said she wants a continuing resolution that extends enhanced ACA subsidies for two years, in addition to addressing some fiscal year 2026 appropriations and funding for the public media.
    • “Both of these were messaging bills,” she said. “They both did what everybody predicted was going to happen, which was, they were going to go down.
  • STAT News reports good news from Atlanta,
    • “A government advisory committee voted unanimously Friday to recommend that individuals 6 months and older should discuss the risks and benefits of Covid-19 vaccines with their health care providers before deciding whether to get vaccinated.
    • “The decision, if signed off on by federal health leaders, would preserve insurance coverage for the shots, and is similar to the Food and Drug Administration’s approvals of the updated vaccines earlier this year. The Advisory Committee on Immunization Practices, convened by the Centers for Disease Control and Prevention, emphasized that for people under 65, the benefits of vaccination are most clear for people with risk factors for severe Covid-19.
    • “This vote provides for immunization coverage through all payment mechanisms including entitlement programs such as Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal health insurance marketplace,” a Health and Human Services spokesperson said.”
  • and
    • “A key government advisory committee voted Friday to postpone a vote on whether to delay infants’ first hepatitis B vaccine — temporarily alleviating fears that a new recommendation on shot timing could reverse the significant progress made in controlling the disease’s spread in recent decades.
    • “The decision followed a lengthy deliberation on Thursday by the newly reconstituted Advisory Committee on Immunization Practice, which pressed scientists from the Centers for Disease Control and Prevention on the necessity of the birth dose, and brought into question the veracity of the data presented on the risks and benefits of the vaccine. But ultimately, members voted to push the vote.”
    • “I believe that there’s enough ambiguity here and enough remaining discussion about safety, effectiveness, and timing that I believe that a vote today is premature,” Robert Malone, a member of the committee, said on Friday. All of the members of the committee, except its chair, Martin Kulldorff, voted to table the vote.”
  • Per a Congressional news release.
    • “Today, U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, released a statement on the Advisory Committee on Immunization Practices (ACIP) postponing a vote to change the recommendation for the hepatitis B vaccine for newborns. If a recommendation for a vaccine is altered without a scientific basis, insurance companies may decide to no longer cover it for patients free of charge. Additionally, doctors will lack the necessary information to counsel families, so they make the best health care decisions for their children.
    • “At Wednesday’s hearing, Cassidy underscored the importance of families having access to the hepatitis B vaccine at birth.”
  • Here is an informative Blue Cross link to an article about No Surprises Act abusive practices by providers particularly in the arbitration / IDR process.  In my opinion, which supplements the Blue Cross recommendations, the NSA arbitration process would be more equitable if the Tri-Agencies added more substance from the AAA baseball / final offer rules to its IDR procedures. 
  • Beckers Payer Issues informs us,
    • “CMS has finalized a rule requiring Medicare Advantage plans to submit provider directory data for inclusion in the Medicare Plan Finder. 
    • “The change, aimed at improving transparency and beneficiary decision-making, takes effect January 1, 2026.
    • “Under the rule, MA plans must make provider directory information available to CMS in a standardized format for online publication, update the data within 30 days of becoming aware of changes, and attest at least once a year to the accuracy of the information.
    • “CMS said the move is designed to allow beneficiaries to more easily compare provider networks across plans without having to navigate multiple websites. The agency expects to publish an operational guide in the coming months with technical specifications for plans to follow, along with a testing period before the data appears publicly online.”
  • The American Hospital Association News explains that this CMS rule was part of a larger rulemaking.
    • “The Centers for Medicare & Medicaid Services Sept. 18 released a final rule on policy and technical changes to Medicare Advantage, the Medicare Prescription Drug Benefit Program, Medicare Cost Plan Program, and Programs of All-Inclusive Care for the Elderly for contract year 2026. Yesterday’s final rule follows one released in April on other changes for MA and prescription drug programs. In the latest final rule, CMS finalized a requirement aimed at increasing beneficiary access to provider directory data in the CMS Medicare Plan Finder platform.”
  • The Government Accountability Office released a report titled “Urban Hospitals: Factors Contributing to Selected Hospital Closures and Related Changes in Available Health Care Services.”
    • “About half of U.S. hospitals are in urban areas. More urban hospitals closed than opened from 2019 to 2023.
    • “All of the 5 hospitals in our review struggled financially before they closed, with inpatient volumes decreasing at 4 of them. The anticipated cost of upgrading or maintaining aging facilities also contributed to the closures of all 5 hospitals.
    • “After closure, 2 of the hospitals still provided outpatient services, while the other 3 stopped all services.
    • “Representatives from local hospitals, providers, and community organizations told us some community residents continued having trouble getting health care after all 5 hospitals closed.”
  • Last but not least, OPM Director Scott Kupor released his regular Friday blog post which concerns OPM’s mine in Boyers, PA, that holds paper personnel records.
    • “The Boyers mine is but one of many examples of opportunities for modernization across the federal government. None of these challenges are rocket science – maybe with the exception of our friends at NASA – but they have been plagued for too long by a system that doesn’t demand inventiveness and efficiency as first-class citizens in the government vernacular. OPM aims to create fluency in this new language – and we are starting with one retirement piece of paper at a time.”

From the Food and Drug Administration front,

  • The New York Times reports,
    • “The cancer medication Keytruda is the world’s best-selling drug. But with lower-priced competition set to arrive as soon as 2028, Keytruda’s manufacturer, Merck, is on the brink of losing tens of billions of dollars in sales.
    • “To keep Keytruda revenue flowing, Merck followed a well-worn playbook. It developed a new version of the drug, given as a shot under the skin, which the Food and Drug Administration approved on Friday.
    • “The company is talking up the new version as quicker and easier for patients than the original therapy, which is given through tubes as an intravenous infusion.
    • “Keytruda is approved to treat 18 types of cancer, including of the skin, lung, breast and colon. It has been given to 2.9 million patients and helped former President Jimmy Carter extend his life by nearly a decade. Since arriving in 2014, Keytruda has generated $146 billion in sales for Merck. The drug accounts for nearly half of Merck’s revenue.”
  • Per MedPage Today,
    • “The FDA approved the Altaviva implantable nerve stimulator for urge urinary incontinence (UUI), a common symptom of overactive bladder (OAB), Medtronic announced.
    • “Inserted near the ankle in a minimally invasive procedure, the device generates low-level electronic impulses that stimulate the tibial nerve to restore bladder-brain communication. The device is the third tibial neuromodulator for UUI, joining the eCOIN device approved in 2022opens in a new tab or window and the Revi System approved in 2023.
    • “The Altaviva device represents a significant advancement for patients with urge urinary incontinence who often weigh the invasiveness of a therapy and the potential side effects when considering treatment options,” Kevin Benson, MD, of Sanford Health in Sioux Falls, South Dakota, said in a statement. “I’m excited to offer my patients this simple experience and believe the Altaviva device has the potential to transform lives and bring new hope to more people.”
  • Per MedTech Dive,
    • “The Food and Drug Administration has published an early alert about risks posed by Abbott’s Tactiflex Ablation Catheter.
    • “Officials published the alert Thursday in response to Abbott writing to customers. The company updated its instructions after reviewing three reports of catheter tips detaching in patients. 
    • “Abbott had not received any reports of serious injuries or deaths as of Sept. 11. However, the potential for harm led the FDA to class the safety action as a potentially high-risk issue.”
  • Per an FDA news release,
    • “Today, the U.S. Food and Drug Administration granted accelerated approval to Forzinity (elamipretide) injection as the first treatment for Barth syndrome, in patients weighing at least 30 kg. Barth syndrome is a rare, serious and life-threatening disease of the mitochondria (the energy-producing parts of cells).
    • “The FDA remains committed to facilitating the development of effective and safe therapies for rare diseases and will continue to work diligently to help ensure patients with rare diseases have access to innovative treatments,” said George Tidmarsh, M.D., Ph.D., Director of the FDA’s Center for Drug Evaluation and Research.
    • Barth syndrome primarily affects males, typically starts with severe heart failure in infancy, and causes premature death. Patients who survive into adolescence and adulthood often have fatigue, poor stamina, and exercise intolerance. The quality of life and daily functioning of patients with Barth syndrome are significantly affected throughout their lives.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity has peaked and is declining in many areas of the country, but emergency department visits and hospitalizations are elevated nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is declining nationally. Emergency department visits for COVID-19 are highest in children 0-4 years old and elevated in adults 65 years and older. Hospitalization numbers are elevated in adults 65 years and older.
    • “Influenza
    • “RSV
      • “RSV activity is very low nationally.
  • The AHA News points out,
    • “The Department of Health and Human Services Sept. 18 announced it will take new actions to help improve care for individuals with long COVID. They include a public awareness and education campaign; the launch of an online platform for physicians, researchers and health systems to share best practices and clinical insights; and an Agency for Healthcare Research and Quality report also released Sept. 18 that covers the sources of health coverage for adults with long COVID.” 
  • Fierce Pharma lets us know,
    • “The Centers for Disease Control and Prevention (CDC) has come out with a strong recommendation for the use of Gilead Sciences’ twice-yearly HIV pre-exposure prophylaxis (PrEP) med Yeztugo, representing a step forward on the road to wider U.S. adoption of the med. Still, work remains to increase access for all who need it, advocacy groups warn. 
    • “The CDC PrEP Guidelines Work Group issued its clinical recommendation in a Sept. 18 Morbidity and Mortality Weekly Report (PDF), pointing to Gilead’s Purpose 1 and Purpose 2 trials. The studies, which also formed the backing of the FDA’s June approval, showed a respective 100% efficacy among females and 96% efficacy among a mostly male trial population compared with background HIV incidence.
    • “Based on the studies, the CDC “strongly recommends” Yeztugo (lenacapavir) as an HIV PrEP option in those who would benefit from PrEP, noting that the drug “has the potential to improve PrEP adherence and thus enhance HIV prevention.”
  • Per Health Day,
    • “Aspirin can cut by more than half the risk that colon cancer will come back following initial treatment, a new clinical trial has found.
    • “Daily aspirin reduced by 55% the risk of cancer recurrence in patients whose colorectal cancer is driven by a genetic mutation, researchers reported Sept. 17 in the New England Journal of Medicine.
    • “Aspirin is a drug that is readily available globally and extremely inexpensive compared to many modern cancer drugs, which is very positive,” lead researcher Anna Martling, a professor of molecular medicine and surgery at Karolinska Institute in Sweden, said in a news release.
    • “The study focused on people whose colon cancer was driven by a mutation of the PIK3 gene, which helps regulate cell growth and division in the human body.
    • “Every year, about 107,320 new cases of colon cancer and 46,950 cases of rectal cancer are diagnosed in the United States, according to the American Cancer Society.”
  • NBC News reports,
    • “Wildfire smoke is responsible for tens of thousands of deaths each year and will do more harm to U.S. residents by midcentury than any other threat driven by climate change, including extreme heat. 
    • “That’s the conclusion of a new research paper that provides some of the most extensive modeling of the growing health toll of wildfire smoke on public health in the U.S. 
    • “The study, which was published in the journal Nature on Thursday, found that each year, on average, wildfire smoke is causing more than 41,400 excess deaths, or more than would be normally expected without smoke given the demographics of the U.S. That figure is more than twice what was previously recognized in other studies. 
    • “By midcentury, the study’s authors expect that number to grow by an additional 26,500 to 30,000 deaths as human-caused climate change worsens and the risk of wildfires igniting increases. 
    • “Wildfire smoke is a much larger health risk than we might have understood previously,” said Marshall Burke, a professor of environmental social sciences at Stanford University and a study author.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Health systems are working directly with employers to improve cancer care and lower costs as demand — and employers’ healthcare expenses — surge.
    • “Providers are gearing up to treat more cancer patients, hoping to ease employers’ mounting frustration with steep premium increases, long appointment wait times and unnecessary treatment, health system and care navigation company executives said. Cutting out insurers through direct contracts could add transparency to employers’ healthcare costs and help standardize treatment strategies, they said.
    • “Employers and unions have no choice but to take a really hard look at solutions that are going to steer patients to high-quality and lower-cost care,” said Emily Kauff, executive director of Memorial Sloan Kettering Cancer Center’s MSK Direct. “Employers are in crisis — they need lower costs and better value in cancer care.”
  • Beckers Payer Issues adds,
    • “Patients who get primary care from older adult-focused, value-based care organizations are more likely to use these services regularly, according to a study published in NEJM Catalyst: Innovations in Care Delivery, a digital journal published by The New England Journal of Medicine. 
    • “The study, produced by Humana Healthcare Research and Suhas Gondi, MD, attending physician at Boston-based Massachusetts General Hospital, covered 3.2 million Medicare Advantage members and included six older adult-focused facilities, most full-risk practices, according to Humana Chief Medical Officer Kate Goodrich, MD. The team found value-based care — as opposed to physicians offering a greater volume of services — is linked to increased use of primary care services.
    • “The exciting thing about this paper is that it shows that in those higher or more mature types of practices that are focused on seniors, they’re getting more primary care, and they’re getting more consistent primary care,” Dr. Goodrich told Becker’s.
    • “This research builds from a 2024 study on how older adult-focused organizations can increase access to primary care, particularly among underserved populations.”
  • Per Modern Healthcare,
    • “UnitedHealth Group has named Sandeep Dadlani CEO of its Optum Insight technology arm, Dadlani announced in a social media post Thursday. 
    • “Dadlani previously served as UnitedHealth’s executive vice president and chief digital and technology officer. He succeeds Dhivya Suryadevara, who had served in that role and CEO of the Optum Financial healthcare banking division since May.
    • “In a LinkedIn post, Dadlani wrote that it was his first week as CEO of Optum Insight, which includes the Change Healthcare claims processing division.” 
  • and
    • “VillageMD is selling 32 Texas clinics to Harbor Health, an Austin-based primary and specialty clinic group that also offers health plans.
    • “The deal includes 10 clinics in Austin, 10 in San Antonio, six in El Paso and six in Dallas. More than 80 clinicians will join Harbor as part of the transaction, according to a Thursday news release. 
    • “Financial details were not disclosed.”
  • Beckers Payers Issues looks into why Blue Cross of Massachusetts consistently achieves a very high NCQA scorecard.

Thursday report

David Ermer–ACA, CDC, CMS, Congress, COVID-19 vaccine, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, NCQA, Obesity, OPM, U.S. Healthcare–

From Washington, DC

  • Roll Call reports,
    • “Top Senate Republicans and Democrats reached a deal Thursday night to tee up two votes on Friday on the two parties’ competing approaches to averting a partial government shutdown when current agency funding expires at the end of the month.
    • “Under the agreement announced by Senate Majority Leader John Thune, R-S.D., and Minority Leader Charles E. Schumer, D-N.Y., assuming the House passes the GOP-drafted, seven-week continuing resolution, then the Senate would take up Democrats’ alternative proposal first. That would be subject to a 60-vote threshold for passage.
    • “If Democrats can’t get 60 votes for their bill — which they aren’t expecting — then the chamber would proceed to a vote on the House-passed CR, also with a 60-vote threshold. That vote is also not expected to succeed.”
    • “However, the idea is for the two sides to head home for the weekend armed with proof that they have to start talking to each other about a compromise that can get 60 votes and get to President Donald Trump’s desk in time to prevent a shutdown.
    • “Schumer had proposed the arrangement earlier in the day, with an eye toward getting the initial votes over with in time for senators to attend conservative activist Charlie Kirk’s funeral in Arizona on Sunday.”
  • Roll Call adds,
    • “Democratic and Republican congressional leaders were engaging in a game of shutdown chicken Thursday, the day before the House’s expected vote on a seven-week stopgap bill due Sept. 30 to prevent a lapse in federal agency funding.
    • “House GOP leaders were feeling good about their odds of getting the bill through their chamber Friday morning, although they still had a little work to do on their side shoring up concerns about added member security funds in the continuing resolution being too skimpy, at $30 million. 
    • “Optimistic, but not certain,” House Appropriations Chairman Tom Cole, R-Okla., responded Thursday when asked for his outlook on passage.”
  • Per Congressional news releases
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor and Pensions (HELP) Committee, highlighted the importance of delivering President Trump and Secretary Kennedy’s mission to restore radical transparency at the U.S. Centers for Disease Control and Prevention (CDC) to protect children’s health.
    • “This comes after the HELP Committee held a hearing with former CDC officials Susan Monarez, PhD, and Debra Houry, M.D., about the recent high-profile departures from the agency. To deliver on the President’s mission of radical transparency, the Committee is inviting U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and HHS officials to respond by speaking with Committee members.”
  • and
    • “U.S. Senator Bill Cassidy, M.D. (R-LA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, released a statement following the U.S. Senate passage of the SUPPORT for Patients and Communities Reauthorization Act, which bolsters prevention, treatment, and recovery services for Americans with substance use disorders and mental illness. Earlier this year, the U.S. House of Representatives passed the bill with strong bipartisan support. The SUPPORT Reauthorization Act now heads to President Trump’s desk for signature.
    • “The opioid and mental health crisis is tearing apart families,” said Dr. Cassidy. “The SUPPORT Act equips communities with vital tools to combat this scourge and save lives. I’m grateful to my colleagues for their work to pass this bill and look forward to it being signed into law.”
  • MedTech Dive tells us,
    • “A House of Representatives committee has advanced a bill that would give eligible breakthrough devices four years of Medicare coverage.
    • “The House Ways and Means Committee debated the bill Wednesday, revealing concerns about the risk of fraud, the type of evidence required and the weakening of the Centers for Medicare and Medicaid Services’ authority.
    • “Despite the concerns, the bill received bipartisan support and was passed in a 38 to 3 vote. Two medtech trade groups welcomed progress on a topic that they have lobbied about for years.”
  • Beckers Payer Issues notes,
    • “Senate and House [Democrat] lawmakers have introduced a bill that would bar health insurers from buying independently owned clinics and require existing conglomerates to divert their provider businesses.  
    • “The Patients Over Profits Act would:
      • “Prohibit insurance companies or their subsidiaries from owning Medicare Parts B and C providers 
      • “Require insurers and their subsidiaries who also own Parts B or C providers to divest, and if they do not, a civil lawsuit can be brought by the Federal Trade Commission, state attorneys general, HHS inspector general or the Justice Department’s antitrust division. 
      • “Bars the HHS secretary from contracting with a Medicare Advantage organization that also owns a Part B or C provider.” 
  • and
    • “Three Medicare Advantage plans scored a full five stars in this year’s health plan rankings from the National Committee for Quality Assurance.
      • Kaiser Foundation Health Plan in Southern California – HMO
      • Kaiser Foundation Health Plan in Northern California – HMO
      • Network Health in Wisconsin – PPO
    • “An additional 17 plans, including six more Kaiser Foundation Health Plans from around the country, scored 4.5 stars in 2025.”
  • The Wall Street Journal reports,
    • Health secretary Robert F. Kennedy Jr.’s handpicked slate of vaccine advisers voted [8-3] to no longer recommend a combined shot for measles, mumps, rubella and varicella [chickenpox (MMRV)] for children under age 4. 
    • The move came as some states, insurers, public health leaders and a U.S. senator called into question whether Americans should rely on the committee’s decisions.
  • The FEHBlog listened to a good chunk of today’s meeting, and the ACIP decision was based on a concern about children under age 4 suffering febrile seizures as a result of the MMRV shot.
  • Per an HHS press release,
    • “The U.S. Department of Health and Human Services (HHS) today announced it is moving to decertify a major organ procurement organization (OPO) after an investigation uncovered years of unsafe practices, poor training, chronic underperformance, understaffing, and paperwork errors. In one 2024 case, a mistake led a surgeon to decline a donated heart for a patient awaiting transplant surgery.
    • “CMS’s decertification of the Life Alliance Organ Recovery Agency, a division of the University of Miami Health System, is part of Secretary Robert F. Kennedy, Jr.’s reform initiative announced in July. At that time, an HHS investigation into another OPO found that at least 28 patients may not have been deceased at the time of organ preparation, 73 patients showed neurological signs incompatible with donation, and the Biden administration had closed its own investigation without action.”
  • OPM Director Scott Kupor added to his blog last Monday September 15 with a post titled “Sorry, Not Everyone Gets an A.” In a related news release, OPM explains Director Kupor’s latest blog post explains why an OPM final rule published September 15 “promotes excellence and accountability.”
  • Federal News Network informs us,
    • “The Office of Personnel Management is putting a pause on plans to relocate some of its employees, but said “new efforts” to do so are underway.
    • “In February, OPM gave remote employees more than 50 miles away from the office an ultimatum: Agree to a “management-directed reassignment” (MDR) and relocate to office space in another geographic region, or face termination.
    • “OPM said it would cover relocation expenses for employees who accept reassignment and gave employees until March 7 to make their decision.
    • “But in a new memo, obtained by Federal News Network, the agency states “relocation efforts for OPM employees are on pause.”
    • “The memo said all employees should continue to work at their current duty station, and that “there is no longer an expectation that the first cohort of employees will be relocated to their new duty station by December 2025.”
    • “The memo suggests OPM is taking a fresh look at relocation plans under OPM Director Scott Kupor, who took office in July.“
  • Tammy Flanagan writing in Govexec, follows up on her article from last week about picking the best date for federal retirement in 2026.

From the Food and Drug Administration front,

  • MedPage Today points out,
    • “The FDA gave premarket approval to the first medical device for the treatment of women with symptomatic moderate-to-severe intrauterine adhesions, known as Asherman syndrome, maker Womed announced on Tuesday.
    • “The resorbable adhesion barrier device (Womed Leaf) is intended for women undergoing hysteroscopic surgery for Asherman syndrome.
    • “Asherman syndrome is caused by scarring of the uterus after procedures such as dilation and curettage or fibroid removal and can occur in 20% to 45% of those procedures. The condition can cause female infertility, pelvic pain, and recurrent miscarriages. Current treatment options for intrauterine adhesions have high recurrence rates.” * * *
    • “Womed said the device will be available in the U.S. in early 2026.”
  • The American Hospital Association News reports,
    • “The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules to laboratory-developed tests. The final rule is in response to a March 31 federal district court decision that also vacated the FDA’s 2024 final rule. The AHA previously urged the FDA to not apply the 2024 final rule to hospital and health system LDTs when it was proposed. 
    • “The AHA appreciates that FDA and the federal district court have acknowledged the unique value and safety of laboratory tests developed by hospitals and health systems for direct use in patient care,” said Roslyne Schulman, AHA director of outpatient payment, emergency readiness and public health policy. “The return to enforcement discretion for LDTs rightly recognizes that applying the device regulations to these tests would likely prompt many hospital laboratories, particularly small ones, to stop offering safe and effective tests upon which patients and their communities rely. This action will help to assure patient access to innovative and targeted diagnostic tests while reducing regulatory burden and costs for both hospitals and the federal government.”
    • “Today’s final rule will become effective following official publication in the Federal Register Sept. 19.”

From the public health and medical/Rx research front,

  • The Wall Street Journal relates,
    • “Novo Nordisk’s daily Wegovy pill led to similar weight loss as the weekly injection in a late-stage trial.
    • “The Wegovy pill, already under review, could be the first GLP-1 pill approved for weight loss.
    • “Trial results showed improved cardiovascular risk factors and increased daily activity for patients.
    • “Currently, less than 2% of individuals with obesity in the U.S. receive obesity medication and Wegovy in a pill may also address patient preference for oral treatment,” Martin Holst Lange, chief scientific officer and head of research & development at Novo Nordisk, said.
    • “Pending FDA approval, ample supply will be available to meet the expected U.S. demand as we hope to set a new treatment benchmark for oral weight loss medications,” he added.”
  • and
    • “Lilly and Novo Nordisk haven’t disclosed specific pricing plans for their pills, but some analysts expect them to be priced at a discount to the injectables.
    • “The leading weekly injected medicines, Novo Nordisk’s Wegovy and Lilly’s Zepbound, have been highly effective at helping people lose significant weight. Zepbound’s highest dose has been shown to help people lose an average of more than 22% of their body weight after more than a year of treatment, while Wegovy can help people lose about 17%. 
    • “Yet their manufacturers have struggled to make enough to meet demand, partly because of limited manufacturing capacity for the complex task of making sterile injectable drugs packaged in an auto-injector device. Making pills is less complex, and there is more global capacity. And, pills don’t require cold-chain distribution and storage, while the injectables need to be kept refrigerated.” * * *
    • “Novo Nordisk may be constrained in how much of its new weight-loss pill it can manufacture because it must cram a lot of the main ingredient into each pill to ensure each person absorbs enough by ingestion, analysts have noted. That is because, like injected semaglutide, the pill is made up of peptides, which are larger than the small molecules that pills are traditionally made of.” * * *
    • Lilly took a different approach than Novo Nordisk. The main ingredient for its GLP-1 pill, orforglipron, is a small molecule, meaning the pills can be manufactured in a more traditional way.
  • Fierce Pharma adds,
    • “Over the last six years, three GLP-1 drugs have been approved for children aged 10 and older with type 2 diabetes. Now this rapidly growing patient population is a step closer to gaining access to Eli Lilly’s dual-action GLP-1/GIP treatment Mounjaro, as its effectiveness in controlling blood sugar has been demonstrated in a phase 3 trial of kids ages 10-17.
    • “The SURPASS-PEDS study—which enrolled 99 children with type 2 diabetes who do not get adequate blood sugar control with metformin, insulin or a combination of both—achieved its primary and secondary endpoints. After 30 weeks of treatment, Mounjaro provided improvements over placebo in the blood sugar measurement, A1C, and in patients’ body mass index (BMI).
    • “The study’s primary endpoint was accomplished, with Mounjaro-treated patients experiencing an average A1C reduction of 2.2% versus .05% for those on placebo from a mean baseline of 8.05%.
    • “Lilly said that it has submitted the results to regulators in a bid to gain an expanded indication for the juggernaut diabetes medication.”
  • Genetic Engineering and Biotechnology News lets us know,
    • “Researchers led by a team at INSERM and King’s College London have shown how stretching the skin stimulates immune cells and increases the skin’s ability to absorb large molecules, including those present in vaccines.
    • “Using a device that applies suction pressure to stretch the skin, the researchers reported that skin stretching activated a local immune response and increased skin permeability without tissue damage via the opening of hair follicles. They also reported that applying vaccines topically while stretching the skin resulted in more effective immunization than subcutaneously injecting the vaccine in mice.”
    • “Just stretching the skin was more effective than delivering the same vaccine with a needle, which shows the practical relevance of this immune activation,” said Stuart Jones, PhD, at King’s College London. “This new pathway into the skin could be used in lots of different ways—we showed its potential for vaccine delivery, but we’re also starting to think about delivering cell therapies and whether it could be used for diagnostics.”
  • Per Healio,
    • “People with obesity and diabetes who undergo bariatric surgery face a significantly lower risk for several adverse health outcomes vs. those treated with GLP-1s, new data show.
    • “Surgery should not be reserved as a last resort; it should be part of early, shared decision-making for patients with type 2 diabetes and obesity,” Ali Aminian, MD, director of Cleveland Clinic’s Bariatric and Metabolic Institute, told Healio. “Evidence shows that surgery provides added, durable benefits beyond medications alone.”
  • Per MedPage Today,
    • “Oral bacteria and fungi may help reshape the pancreatic microbiome and promote carcinogenesis.
    • “Earlier research has connected periodontal disease and clinical candidiasis with greater pancreatic cancer risk.
    • “Altogether, the study identified a more than threefold increase in cancer risk for everyone standard deviation rise in a microbial risk score comprised of 27 bacteria and fungi.”
  • and
    • “One in 10 childhood blood cancers may result from medical imaging-associated radiation exposure.
    • “Cancer risk increased with cumulative radiation dose, ranging from 1.41 times higher to 3.59 times higher.
    • “Children exposed to at least 30 mGy had 25.6 excess blood cancers per 10,000 by age 21.”

From the U.S. healthcare business front,

  • Fierce Healthcare reports,
    • “Ascension wrapped its 2025 fiscal year with a $490.9 million operating loss (-1.9% operating income) but a $917.7 million net income, an improvement over the prior year it attributed to greater volumes, improved labor productivity and a tighter rein on non-labor spending.
    • “The major Catholic nonprofit is coming off of a $1.8 billion operating loss in fiscal 2024 and a $3 billion operating loss in fiscal 2023, though those dip to $1.4 billion and $1.5 billion, respectively, when removing impairment and nonrecurring losses. It’d also suffered a major cybersecurity incident at the end of fiscal 2024, the recovery from which leadership said spanned multiple quarters and included consistent volume recovery.
    • “We have been intentional in directing resources toward initiatives that generate measurable impact, from service line growth to process redesign, while also ensuring both stewardship and sustainability,” Saurabh Tripathi, executive vice president and chief financial officer, said in a statement. “This combination of operational discipline and strategic investment increases our flexibility to expand access, enhance services, and ensure the commitment to our mission.”
    • Ascension, which owns or has interests in about 120 hospitals and other healthcare facilities across 16 states, logged $25.3 billion of total operating revenue in fiscal 2025, a roughly $3.2 billion decline (-11.3%) largely reflecting the system’s recent divestments.”
  • The Wall Street Journal relates,
    • “Roche ROG Holding said it agreed to buy 89bio ETNB for up to $3.5 billion, seeking to bolster its drug pipeline by adding an experimental treatment for a liver disease linked to obesity.
    • “The Swiss drugmaker has been looking to enter the weight-loss drug field, a key target of its recent dealmaking activity. With Eli Lilly and Novo Nordisk ahead in the race due to approved drugs that are generating billions of dollars in sales, Roche is betting that a new generation of treatments and potential drug combinations for adjacent conditions can help it to carve out a future role in the market.
    • “The main asset in the pipeline of San Francisco-based 89bio is a drug candidate for a fatty liver disease known as MASH, or metabolic dysfunction-associated steatohepatitis, that is mostly due to obesity.
    • “We intend to be a leader in the cardiovascular space going forward, and being a player in the obesity space is important to make that happen,” Teresa Graham, chief executive of Roche Pharmaceuticals said in an interview.”
  • Per Modern Healthcare,
    • “Cigna aims to strengthen its grip on the specialty pharmacy market through a recent deal with Shields Health Solutions.
    • “The company’s Evernorth Health Services subsidiary, which includes the pharmacy benefit manager Express Scripts and the specialty pharmacy Accredo, announced a $3.5 billion investment into Shields Health Solutions on Sept. 2.
    • “The move shores up a slice of the specialty pharmacy market Cigna wanted to bolster, President and Chief Operating Officer Brian Evanko said during the Morgan Stanley Global Healthcare Conference Sept. 10.” * * *
    • “What caught a lot of people off guard by the [Cigna] transaction is it’s not intuitively the best fit with a retail-oriented PBM,” said Aryeh Sand, a partner at investment banking firm Solomon Partners. “Shields historically is more aligned with health systems.”
  • and
    • “Ten Wisconsin rural hospitals formed a clinically integrated network, following dozens of rural providers that have joined similar initiatives over the past two years. 
    • “The Wisconsin High Value Network looks to pool the expertise and scale of the independent rural hospitals, which have combined $880 million in net revenue, to improve care and lower costs. The Cibolo Health-backed network, announced Thursday, will give providers the data infrastructure and bargaining power to hone primary care services and expand alternative payment models, said David Hartberg, CEO of Vernon Health in Viroqua, Wisconsin, and board chair of the Wisconsin High Value Network.
    • “Cibolo, a rural hospital advisory firm, helped launch similar coalitions in North Dakota, Minnesota, Ohio, Montana and Nebraska. Cibolo will manage daily operations of the Wisconsin High Value Network.”
  • Per BioPharma Dive,
    • “Biogen is buying Alcyone Therapeutics after working with the company for more than two years on a better delivery system for neurological medicines built around antisense oligonucleotides.
    • “Under terms announced Thursday, Biogen will spend $85 million upfront to acquire the privately held company and promise additional payments to Alcyone investors if certain development and regulatory goals are reached. Biogen will gain all rights to ThecaFlex DRx, an implantable subcutaneous port and catheter device it’s been developing with Alcyone since 2023.
    • “The companies have two studies underway testing the system’s delivery of Biogen’s Spinraza drug for spinal muscular atrophy, Biogen said. Lowell, Massachusetts-based Alcyone has been developing ThecaFlex DRx since 2019 and manufactures the product locally.”
  • Per MedTech Dive,
    • “Siemens Healthineers and Stryker are partnering to develop a robotic system that can perform a range of elective and emergency neurovascular procedures, including treatment for strokes and aneurysms, the companies said Wednesday.
    • “The collaboration includes system design, access device and implant integration, imaging for robotic navigation and procedural workflow optimization. The project will combine Siemens Healthineers’ expertise in robotics and imaging with Stryker’s experience in neurovascular technologies.
    • “Carsten Bertram, head of advanced therapies at Siemens Healthineers, said the partnership will focus on creating an ecosystem of image guidance, robotics and devices to help physicians provide faster and more precise care to patients.”
  • Per Fierce Pharma,
    • “With both companies on an upward trajectory, argenx and its manufacturing partner Fujifilm Biotechnologies are taking a logical next step by expanding their collaboration.
    • “In addition to manufacturing drug substance for argenx’s autoimmune blockbuster Vyvgart at its facility in Hillerød, Denmark, Fujifilm will also make the product at its large-scale complex in Holly Springs, N.C. The CDMO will initiate production of Vyvgart at the plant in 2028.
    • “Fujifilm’s Holly Springs is slated to become operational this year and has already secured contracting work from several large drugmakers.” * * *
    • “Fujifilm began building the $2 billion Holly Springs campus in 2021, billing it then as the largest end-to-end biologics production plant in the world, with the expectation to employ roughly 725 at the facility.
    • “Then, in April of last year, Fujifilm upped its ante on the site, earmarking an additional $1.2 billion for its construction and increasing its expected headcount at the facility to 1,400 by 2031.” 

From the artificial intelligence front,

  • Beckers Payer Issues reports,
    • “Hawaii Medical Service Association and Blue Cross and Blue Shield of Kansas joined Blue Shield of California as co-founders of Stellarus, according to a Sept. 18 news release from the technology company. 
    • “Stellarus said it aims to help health plans of all sizes integrate AI and fresh technology to expedite prior authorization, reduce administrative costs and elevate member experience.
    • “Given Hawaii’s size and geographic position, we are better off if we enhance our ability to innovate and grow our technological capacities by investing in Stellarus with like-minded, mission-driven, not-for-profit health plans that are trying to accomplish the same things and solve the same problems,” said President and CEO of Hawaii Medical Service Association Mark Mugiishi, MD.” 
  • Beckers Hospital Review lets us know,
    • “Rochester, Minn.-based Mayo Clinic nurses and informatics teams have developed a [patent pending] in-house AI tool to help streamline clinical workflows.
    • “The tool, called the Nurse Virtual Assistant, integrates directly into Mayo’s EHR and provides a nurse-specific patient summary with links to resources including Lippincott guidelines, intravenous administration protocols and a clinical policy library, according to a Sept. 17 news release.
    • “Mayo Clinic said the tool is designed to reduce the time nurses spend navigating multiple systems, allowing them to focus more on patient care. It was tested and validated in a research study approved by Mayo’s institutional review board before being expanded to more than 9,600 nurses across inpatient and emergency department units.”
  • Per AHA News,
    • “The Joint Commission and the Coalition for Health AI released guidance Sept. 17 on the responsible use of artificial intelligence in health care, the first installment from their partnership that launched in June. The guidance includes recommendations on AI policies, local validation, monitoring and use for interpretation and integration into new or existing processes. CHAI and the Joint Commission plan to release further guidance and a playbook by year’s end.”

Tuesday report

David Ermer–Congress, FDA, Generative AI, Medical / Rx research, Medicare, NCQA, NIH, Obesity, OPM, Rx coverage, U.S. Healthcare–

From Washington, DC,

  • An OPM news release tells us,
    • U.S. Office of Personnel Management (OPM) Director Scott Kupor joined the Ruthless Podcast to discuss a number of wide-ranging topics including OPM’s ongoing efforts to bring top talent into the federal workforce and enhance operational efficiency across government.
    • WATCH HERE
  • The American Hospital Association News informs us,
    • “The House Appropriations Committee today released bill text for a continuing resolution to fund the government through Nov. 21. The bill also extends key health care programs set to expire Sept. 30 through the length of the CR. They include extending the Medicare-dependent Hospital and low-volume adjustment programs, telehealth and hospital at home flexibilities, delaying Medicaid Disproportionate Share Hospital cuts, and extending the Cybersecurity Information Sharing Act. The House is expected to vote on the measure this week. The Senate will follow in an attempt to avert a government shutdown by Sept. 30.”
  • Politico adds,
    • “A group of GOP senators are working on legislation to extend Affordable Care Act subsidies with policy changes designed to win over conservatives, according to four people granted anonymity to disclose private discussions.
    • “This group has gotten “technical assistance” from the Senate Finance Committee, which has jurisdiction over the subsidies, according to two of the sources. The Obamacare subsidies are set to expire at the end of this year.”
  • Per the AHA News,
    • “The House Ways and Means Oversight Subcommittee today hosted a hearing on tax-exempt hospitals. The AHA submitted a statement for the hearing, highlighting the amounts that tax-exempt hospitals spend annually on community benefits and where those funds are spent. The AHA also highlighted its analysis released Sept. 10 that found tax-exempt hospitals provided nearly $150 billion in total benefits to communities in 2022, marking a nearly 50% increase in community benefit spending from 2017. Additionally, the AHA explained why a flexible community benefit approach is best for communities as opposed to suggestions for a definition and evaluation from the Internal Revenue Service.” 
  • Per a Congressional news release,
    • Sens. Chuck Grassley (R-Iowa) and Ben Ray Luján (D-N.M.) reintroduced bipartisan legislation bolstering pharmacists’ ability to serve older Americans in communities that lack easy access to doctors or where pharmacists can provide certain basic medical services.
    • The Pharmacy and Medically Underserved Areas Enhancement Act encourages pharmacists to offer health care services (like health and wellness screenings), immunizations and diabetes management by authorizing Medicare payments for those services where pharmacists are already licensed under state law to provide them. Many states already allow pharmacists to provide these services. However, there is currently no way for pharmacists to receive Medicare reimbursement for providing them. * * *
    • “Grassley and Luján also requested feedback from stakeholders on pharmacists providing services for chronic care needs, given the unique pressing challenges of chronic care among seniors. Text of the request-for-information (RFI) can be found HERE.
    • “The full text of the legislation is available HERE.”
  • Healthcare Dive reports,
    • “Doctors — especially specialists — are pushing back against proposed changes to Medicare payment that would tamp down on reimbursement next year.
    • “Medicare’s proposed physician fee schedule for 2026 includes a base rate hike of 2.5%. But it also includes an efficiency adjustment that would reduce payment by 2.5% for thousands of procedures and changes to how regulators calculate practice expense that would lower reimbursement for services performed in facilities like hospitals.
    • “The reforms are meant to account for increased efficiency in procedures that doctors perform frequently, realign payment for primary and specialty care, and recognize larger indirect costs for doctors in office-based settings.
    • “Many physicians support those goals. But the policy changes themselves are a bad idea, doctors are warning the CMS.”
  • Fierce Healthcare points out,
    • “In its annual health plan ratings, the National Committee for Quality Assurance (NCQA) found that 11 out of 998 rated plans earning top marks, more than double last year’s total. 
    • “Of the 11 plans to achieve a 5-star rating, eight were commercial plans and three were Medicare plans. They included Blue Cross and Blue Shield of Massachusetts, UPMC Health Plan and several Kaiser Foundation Health Plans.  An additional 55 plans earned a 4.5-star rating. Most plans ranked between 3 and 4 stars, same as in 2024. The NCQA says its ratings help consumers and regulators assess the quality and effectiveness of health plans. 
    • “The report found year-over-year improvements in coordination and continuity of care in Medicare. The NCQA also identified progress across nearly all six diabetes-related measures. The Kidney Health Evaluation for Patients with Diabetes metric showed an average increase of over 5% across all product lines. 
    • “Additionally, the NCQA found improved adult and adolescent immunization rates. Though childhood immunization rates continued to decline, they did so at a slower pace than last year.”

From the Food and Drug Administration front,

  • Cardiovascular Business relates,
    • “A safety issue with certain Boston Scientific defibrillation leads has resulted in a series of new Class I recalls, according to the U.S. Food and Drug Administration (FDA). Unlike some recalls, these do not require a product to be immediately removed from the market. However, there are specific recommendations all clinicians should follow. 
    • “The FDA first shared details with the public about these concerns in early August, noting that some of Boston Scientific’s single- and double-coil Reliance defibrillation leads coated with expanded polytetrafluoroethylene (ePTFE) were associated with a potential risk of rising low-voltage shock impedance (LVSI). If this occurs, it can make the leads less effective over time. 
    • “The most common harm is early lead replacement, and the most serious harm is death or need for cardiac resuscitation due to non-conversion of a sustained ventricular arrhythmia from a reduced shock energy due to high impedance,” the agency said at the time.”
  • The AHA News adds,
    • “The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore its neutral setting and allows it to move unexpectedly. The FDA said there has been one reported injury and no deaths related to the issue.” 
    • “In addition, the FDA issued an early alert for certain Medline convenience kits containing Medtronic DLP Left Heart Vent Catheters due to issues found with certain lots of cannula products where the catheter may not retain its shape. Medline sent a notice to affected customers that recommended they destroy any affected product after completing the list of recall actions.” 

From the public health and medical/Rx research front,

  • The Wall Street Journal reports,
    • “Novo Nordisk’s Wegovy weight-loss drug helps patients stop thinking about food, according to a new study.
    • “According to results of the study, which were presented at a medical conference in Austria, patients taking Wegovy for weight-loss experienced a substantial drop in so-called “food noise”—unwanted and intrusive thoughts about food—alongside improvements in their mental well-being and lifestyle.
    • “Novo Nordisk said the number of people who reported experiencing constant thoughts about food throughout the day declined by 46% after starting treatment with Wegovy, while 64% of respondents reported improved mental health and 80% reported healthier habits while taking the drug.
    • “It is very encouraging to see these new data from people using Wegovy that, in addition to weight-loss, Wegovy may help quiet disruptive thoughts about food, support improved mental well-being and help enable people to live healthier lives,” said Filip Knop, incoming chief medical officer at Novo Nordisk.
    • “The U.S.-based Inform study released Tuesday surveyed 550 people taking Wegovy for weight-loss to assess the impact of the drug on mental well-being and eating habits relating to food noise.”
  • MedPage Today adds,
    • “A higher 7.2 mg dose of semaglutide led to significantly greater weight loss compared with placebo in adults with obesity, with or without type 2 diabetes.
    • “Participants across two randomized trials also had improvements in cardiovascular risk factors.
    • “Secondary and exploratory analyses suggested that the 7.2 mg dose led to a greater change in body weight versus the currently approved highest dose of 2.4 mg.”
  • Per a National Institutes of Health news release,
    • ‘The National Institutes of Health (NIH) has launched effort aimed at reducing the rate of preventable stillbirths in the United States. Investigators will develop tools, devices and other technologies that have the potential to affect diagnosis and prevention efforts relevant to stillbirth, which occurs in 1 in 160 deliveries in the U.S. About 23,600 stillbirths at 20 weeks or greater gestation are reported annually.
    • “More than 60% of stillbirth cases remain unexplained even after exclusion of common causes, such as congenital abnormalities, genetic factors, and obstetric complications. NIH will fund the Stillbirth Research Consortium for more than $37 million over five years, pending the availability of funds, with $750,000 in co-funding from the Department of Health and Human Services.
    • “This consortium will provide an integrated, collaborative program to support cutting edge research to identify the root causes of stillbirth and inform evidence-based strategies to address stillbirth risks,” said Alison Cernich, Ph.D., acting director of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development. “Too many families needlessly face the grief of stillbirth.”
    • “People who have experienced stillbirth are almost five times as likely to experience another stillbirth or other pregnancy associated complication. The rate of stillbirth is considerably higher among Black, American Indian, and Alaska Native people. About 40% of stillbirths that occur during labor and birth are considered potentially preventable.” 
  • Genetic Engineering and Biotechnology News reports,
    • “A novel strategy developed by scientists at Rice University allows scientists to zoom in on tiny segments of proteins inside living cells, revealing localized environmental changes that could indicate the earliest stages of diseases such as Alzheimer’s, Parkinson’s, and cancer. The study results could offer promise for drug screening that targets protein aggregation diseases.
    • “The research team engineered a fluorescent probe known as AnapTh into precise subdomains of proteins, creating a tool that monitors microenvironmental shifts in real time. Unlike conventional techniques that provide only broad signals, this approach reveals how distinct regions of the same protein behave differently during the aggregation process. The work, led by Han Xiao, PhD, professor of chemistry and director of Rice’s SynthX Center, enhances the basic understanding of disease mechanisms and lays the groundwork for identifying drug targets and screening potential therapeutics at an earlier stage.
    • “We essentially built a molecular magnifying glass,” Xiao said. “This allows us to visualize subtle environmental changes that previously went unnoticed, and those early changes often hold the key to understanding protein-related diseases.” Xiao and colleagues reported on their findings in Nature Chemical Biology, in a paper titled, “Real-time imaging of protein microenvironment changes in cells with rotor-based fluorescent amino acids,” in which they concluded: “These results demonstrate that the technology reported in this paper provides a versatile tool for exploring microenvironment changes of protein substructures at high spatial resolution, enabling direct visualization of the local environment around specific amino acid residues.”

From the U.S. healthcare business front,

  • The Wall Street Journal reports,
    • “Eli Lilly LLY unveiled plans to build a $5 billion manufacturing facility in Virginia as part of the drugmaker’s pledge to bolster its domestic medicine production with four new pharmaceutical manufacturing sites.
    • “Eli Lilly said the new plant, located just west of Richmond in Goochland County, will be the first dedicated, fully integrated active pharmaceutical ingredient and drug product facility for its emerging bioconjugate platform and monoclonal antibody portfolio.
    • “The Indianapolis company said the site also will boost its domestic manufacturing of antibody-drug conjugates.
    • “Eli Lilly said the new plant will create more than 650 new company jobs, along with 1,800 construction jobs.
    • “Eli Lilly in February said it would invest $27 billion to build four new pharmaceutical manufacturing sites in the U.S., more than doubling its U.S. capital expansion commitments since 2020 to more than $50 billion.”
  • and
    • “So far this year, more than a dozen drugmakers [, including Lilly,] have pledged to spend more than $350 billion collectively by the end of this decade on manufacturing, research and development and other functions in the U.S., a Wall Street Journal tally of company announcements showed.
    • “The vast majority of our products going into the U.S. are manufactured in the U.S.,” GSK Chief Executive Emma Walmsley said in an interview Tuesday when the company announced its $30 billion U.S. investment in research and development and supply-chain infrastructure over the next five years. “This of course adds to it, and it’s about the new pipeline that’s going through.”
  • Modern Healthcare informs us,
    • “Health systems are revamping pediatric care to fight emergency department overcrowding before Medicaid funding cuts further endanger access. 
    • “Many emergency rooms are full, leading to care delays and provider burnout. Hospital operators have responded by tasking social workers with triage duties and setting up virtual consultations with specialists. They are also consolidating emergency services and asking data analytics companies to better track and predict capacity and utilization trends, health system executives said. 
    • “Health systems have crafted many of these strategies around pediatric patients, who may bear the brunt of the Medicaid cuts authorized by the “One Big Beautiful Bill,” among other federal policy changes, experts said.
    • “The population that will get hit the hardest in emergency medicine will be pediatrics,” said Dr. Ken Heinrich, chief medical officer of emergency medicine at staffing company SCP Health. 
    • “Providers are facing a surge in pediatric mental health issues, fueling care backlogs across hospital emergency departments. Providers have enlisted social workers and adjusted their emergency department layouts to meet that demand.”
  • and
    • “Labcorp has completed its acquisition of BioReference Health’s oncology diagnostic testing assets for up to $225 million. 
    • “The independent laboratory company paid $192.5 million at closing and and could pay up to $32.5 million more in an earn-out tied to the assets’ performance, according to a Monday news release.
    • “Labcorp previously acquired select clinical, reproductive and women’s health diagnostic assets from BioReference last September for more than $237 million.”
  • MedCity News notes,
    • “Berry Street, a nutrition therapy company, has launched its GLP-1 Nutrition Pathway Program, which is meant to provide nutrition support for those starting, taking and getting off of GLP-1s.
    • “The New York City-based company works with health plans and connects patients in need of nutrition support to a network of registered dietitians. It provides personalized treatment plans for patients struggling with weight management, diabetes, heart health, kidney disease and numerous other conditions.”
  • Per a UHC press release,
    • “Building on our March announcement committing to modernize pharmacy payment models, Optum Rx has increased reimbursement minimums for brand drugs for approximately 2,300 independent pharmacies – those not affiliated with a pharmacy services administrative organization (PSAO), chain or other entity – across the country. This move, which went into effect on September 1, 2025, will support the long-term sustainability of pharmacies, which play a critical role in patient care. 
    • “This is the latest announcement from Optum Rx, which continues to expand on initiatives to transform how pharmacies are reimbursed for drugs. Optum Rx first launched improved reimbursement earlier this year, with Epic Pharmacy Network, a PSAO representing more than 1,000 independent pharmacies, being the first PSAO to partner with us.”
  • BioPharma Dive lets us know,
    • “Novartis is broadening its bet on drugs that can destroy disease-causing proteins, agreeing Monday to a new deal with biotechnology company Monte Rosa Therapeutics.
    • “Through the collaboration, the companies will work to develop multiple novel protein “degrading” drugs for immune conditions. Monte Rosa will conduct discovery and early testing before Novartis takes over development for programs it chooses to license. The biotech will get $120 million in upfront cash per deal terms. It could also receive as much as $5.7 billion overall should various development and sales milestones be met, plus royalties on sales of any eventual products.”
    • Monte Rosa is among the many companies pursuing “molecular glue” drugs, which force together a target protein with an enzyme that flags it for destruction by the cell’s waste disposal system. The approach is seen as a way to access tough-to-reach drug targets, and is one of several strategies biotechs are using to degrade harmful proteins, rather than bind and block them as traditional drugs do.
  • Per Beckers Hospital Review,
    • “Amazon has added Fay, a dietitian platform, as the first nutrition care service available through its Health Benefits Connector.
    • “The collaboration allows eligible Amazon customers to discover and enroll in Fay’s insurance-covered nutrition services while browsing for wellness and health benefits, according to a Sept. 16 news release.
    • “Fay connects individuals with registered dietitians based on their goals, health history and insurance eligibility. Services include counseling, preventive care and coaching, which the company said are often available at no cost to patients.”

From the artificial intelligence front,

  • Fierce Healthcare reports,
    • “Healthcare accreditation body URAC is rolling out the nation’s first accreditation program for users and developers of healthcare artificial intelligence. 
    • “The first-in-the-nation program will evaluate risk management, business management and performance monitoring with specific modules for users and developers. URAC accredits organizations ranging from small pharmacies to multistate payer organizations. 
    • The organization, which has been accrediting healthcare organizations for decades, hopes the URAC gold star will help promote trust in AI.
    • “We think that this is a great opportunity to give people that seal of approval, that gold star, that someone independent has gone in behind the scenes and audited to make sure that this is trustworthy,” Shawn Griffin, M.D., CEO and president of URAC, said in an interview.”
  • and
    • “Aegis Ventures’ digital consortium gained three new members as health systems look to collaborate to develop and scale artificial-intelligence-powered health tech solutions and tackle common pain points.
    • “Yale New Haven Health System, Keck Medicine of USC and Hartford HealthCare joined the collaborative, expanding its reach to 14 regional health systems. The consortium, which includes Northwell Health, UPMC, Stanford Health Care and Vanderbilt Health, will codevelop, invest in and deploy health tech solutions alongside Aegis Ventures. 
    • “The partnerships with the three new health systems will accelerate the consortium’s pipeline of companies with two startups set to launch this fall, according to John Beadle, co-founder and managing partner of Aegis Ventures.
    • “Next year, I think we could be more aggressive, just given that the model of the blueprint worked well. We have the right set of partners, the right team, the resources are in place to do it, but I think we’re most focused on seeing this year out really strong,” Beadle said.”
  • and
    • “Healthcare technology and AI company Innovaccer has acquired Story Health, a digital specialty care platform with health system inroads.
    • “Financial terms of the deal, announced Tuesday, were not disclosed. Innovaccer said the deal adds to its scalable Healthcare Intelligence Cloud offering, which in recent months was bolstered by the company’s other strategic acquisitions.
    • “Healthcare doesn’t change through dashboards alone,” Abhinav Shashank, co-founder and CEO of Innovaccer, said in the announcement. “It changes when data and AI power completely new clinical models. Story Health has proven that in specialty care; and we’re excited to bring this technology and clinical expertise to our health system customers nationwide.”
    • “Cupertino, California-based Story Health, a Fierce 15 2024 honoree, launched in late 2020 and has raised about $27 million in funding from backers such as Northpond Ventures, B Capital Group, LRVHealth, Define Ventures and General Catalyst. Its approach combines virtual coaching, biometric monitoring and care team alerts to support patients with chronic conditions between clinical visits.”

Weekend update

David Ermer–Congress, FDA, Medical / Rx research, Obesity, OPM, U.S. Healthcare–

From Washington, DC,

  • The Wall Street Journal reports that the Democrat “Party wants expanded Obamacare subsidies restored in any deal to keep government funded past Sept. 30.”
    • “Democrats are more confident in their negotiating stance compared with March, when a similar attempt to play hardball fizzled. While today’s talks pit them against Republican leaders who want a two-month spending deal with no big additions, they are finding support among rank-and-file GOP lawmakers fearing political backlash if their voters are hit by higher health-insurance bills next year.
    • “Republicans have to come to meet with us in a true bipartisan negotiation to satisfy the American people’s needs on healthcare, or they won’t get our votes, plain and simple,” Senate Minority Leader Chuck Schumer (D., N.Y.) said Thursday.
    • “Senate Majority Leader John Thune (R., S.D.) said he was open to discussions about extending the subsidies, but not as a condition of a short-term spending bill he has proposed to keep the government open into November. Such an extension would give Congress more time to iron out full-year spending deals.
    • “The fight centers on the extension of expiring Affordable Care Act tax credits. The subsidies, which expanded the payments offered under the existing ACA, or Obamacare, were first passed in 2021 by Democrats as a temporary measure tied to a Covid-19 aid law. Republicans didn’t renew them in their sprawling tax-and-spending legislation President Trump signed in July, meaning they will expire at the end of this year.”
  • According to the legislative calendars for the House of Representatives and the Senate, next week is scheduled for a District / State work break which means that we have seven legislative days before the end of federal government’s fiscal year. Fortunately, with respect to prospects for a government shutdown, there is no national election this year so Congress will be in session for the fourth quarter rather than on the campaign trail.
  • The New York Times reports,
    • “The Food and Drug Administration has warned Hims & Hers, a major telehealth purveyor of widely popular obesity drugs, to stop “false or misleading” marketing, according to a copy of a letter sent to the company and obtained by The New York Times.
    • “The F.D.A.’s letter was one of about 100 warning letters sent to drug advertisers this week. The agency commissioner, Dr. Marty Makary, said on Tuesday that the letters were being sent to traditional pharmaceutical companies as well as to online pharmacies.
    • “The letter, sent on Tuesday to Hims & Hers, warned the company to halt the use of marketing language that falsely implies that one of its products is approved by the F.D.A. The agency has not yet publicly released the letter.
    • “Hims & Hers has capitalized on a huge demand for weight-loss drugs like Novo Nordisk’s drug Wegovy, offering low-cost, copycat versions made through a process of mixing drug ingredients known as compounding. In the past few years, telemedicine companies like Hims & Hers have emerged as an aggressive new type of drug advertiser.”

From the judicial front,

  • Federal News Network reports,
    • “A federal judge in San Francisco found the Office of Personnel Management unlawfully directed agencies to fire probationary federal employees en masse.
    • “U.S District Court Judge William Alsup ruled late Friday that OPM “exceeded its own powers,” and “directed agencies to fire under false pretense,” telling probationary employees that they were being terminated for poor performance.
    • “The ruling doesn’t reinstate any of the 25,000 probationary federal employees fired around mid-February, but it does direct many agencies to update their personnel records to specify that these employees were not fired for poor performance or misconduct. Agencies must also send letters to impacted employees starting they were not fired for performance.
    • “The ruling, in a lawsuit led by federal employee unions, applies to the departments of Commerce, Defense, Health and Human Services, Labor, Treasury, Transportation and Agriculture. OPM, NASA, the State Department and the Office of Management and Budget are exempt from the ruling.”

From the public health and medical/Rx research front,

  • The Wall Street Journal explains how to start ditching ultraprocessed foods.
    • “When choosing ready-to-eat snacks and meals, check the label and aim for products that clock in at less than 1.5 calories per gram, says Kevin Hall, a former scientist at the National Institutes of Health who led the agency’s research on ultraprocessed foods before he left in the spring. Ultraprocessed foods are often energy-dense, containing more calories per gram than less-processed foods. 
    • “The particular combinations of fat, sugar, sodium and carbs that ultraprocessed foods often contain aren’t generally found in nature. Researchers call these combinations “hyperpalatable,” and they exert a strong effect on our brain’s reward system, which makes us crave them, says Tera Fazzino, associate director of the Cofrin Logan Center for Addiction Research and Treatment at the University of Kansas.”
  • Medscape considers whether oral GLP-1s can transform the obesity treatment landscape?
    • “Experts agreed that there’s room for a wide variety of obesity medications.
    • “Patients could also consider bariatric surgery, said Karan Chhabra, MD, assistant professor in the Department of Surgery and the Department of Population Health at the NYU Grossman School of Medicine in New York City. He is the coauthor of a study recently presented at the American Society for Metabolic and Bariatric Surgery’s 2025 Annual Scientific Meeting that showed that patients who underwent bariatric surgery experienced significantly more weight loss after 2 years than patients who received weekly injections of semaglutide or tirzepatide.
    • “Expanded access to GLP-1s for chronic weight management could help many people, but only time will tell what the specific impact of oral GLP-1 medications will be [e.g., will oral GLP-1 drugs carry a materially lower price?].”
  • The New York Times Well newsletter offers “five simple steps to calm yourself down. These techniques can help you handle the ups and downs of daily life.”
    • “There are lots of ways to deal with the ups and downs of daily life, Marc Brackett, the founding director of the Yale Center for Emotional Intelligence, told me. He’s developed a framework called RULER — recognize, understand, label, express and regulate — and it’s used in over 5,000 schools nationwide.”

From the U.S. healthcare business front,

  • Modern Healthcare reports,
    • “Imaging company Siemens Healthineers and minimally invasive medical device maker Cook Medical announced a partnership Saturday to offer one of the first turnkey interventional MRI suite solutions.
    • “The solution comprises Siemens Healthineers’ MRI technologies and services like its interventional planning software along with Cook Medical‘s medical devices designed for MRI, including catheters, guidewires and sheaths. Both companies will provide specialized training and ongoing clinical support.
    • “Currently, hospitals that seek to build an interventional MRI suite have to buy the equipment separately and create their own suite.
    • “Interventional MRI provides real-time imaging during minimally invasive procedures including those in oncology for soft tissue tumors, pediatric cases and structural heart conditions. Compared with interventional fluoroscopy and interventional CT, the technology offers superior image quality for soft tissues and eliminates radiation exposure.”
  • and
    • “B. Braun announced Friday it has acquired digital robotic-assisted 3D surgical microscopy company True Digital Surgery for an undisclosed amount.
    • “Previously, B. Braun, a Germany-based global medical device company, held a minority stake in the firm and partnered on developing the Aesculap Aeos robotic digital microscope. The acquisition will allow B. Braun to leverage the firm’s expertise to further advance the microscope’s development.
    • “B. Braun’s surgical division Aesculap launched the microscope in the U.S. in September 2020. It provides surgeons with 3D digital visualization while performing complex ophthalmology, neurosurgery, ENT and spinal surgeries.”
  • BioPharma Dive informs us,
    • “Takeda on Thursday said Rhonda Pacheco will become head of its U.S. business unit on Sept. 29. Pacheco has been at Eli Lilly for more than a decade and, since 2023, has been the group vice president of the pharmaceutical company’s cardiometabolic health unit, where she oversaw the lucrative launches of Lilly’s GLP-1 drugs. At Takeda, she’ll succeed Julie Kim, who was selected this year to take over for retiring CEO Christophe Weber in June 2026 and will serve as “interim” head of the company’s global portfolio ahead of the transition.”
  • Health Exec points out,
    • “Non-profit health system Mayo Clinic said on Monday that it’s planning to close six clinics in Minnesota, its home state, in an effort to remedy staffing shortages. 
    • “Specifically, the clinics in Belle Plaine, Caledonia, Montgomery, North Mankato, St. Peter and Wells will all be shutting their doors forever. In addition, its hospital in Albert Lea will end elective surgeries in some specialties, including gynecology and orthopedics. However, a spokesperson for Mayo Clinic told HealthExec future procedures will be moving to nearby patient care centers. The hospital is still operating as normal, and its emergency room remains open. 
    • ‘Mayo Clinic said the changes will go into effect Dec. 10. It’s launched a resource webpage to answer common questions patients may have, as it says it’s working to transition all of them to new locations. Patients will “receive a letter and portal message explaining the changes” and presenting them with options, the online FAQ confirms. In some cases, that means shifting in-person visits over to telehealth.” 
  • Per HR Dive,
    • “Pay raise budgets for next year are predicted to mirror 2025’s increases, according to a Sept. 3 report from The Conference Board. On average, companies said they plan to up their salary budgets by 3.4% in 2026.   
    • “Actual increases this year were on average 3.4%, lower than the 4% predicted in last year’s survey but still higher than the 3% average seen prior to 2020, The Conference Board said.
    • “Today’s labor market is one of recalibration, not retreat,” Mitchell Barnes, an economist at The Conference Board, said in a news release. “Companies are rebalancing their workforce and labor strategies,” slowing headcount growth and investing in training, Barnes noted.”

Friday report

David Ermer–Congress, COVID-19, FDA, HIPAA Privacy and Security Rules, Medical / Rx research, OPM, U.S. Healthcare–

From Washington, DC,

  • The FEHBlog was pleased to see that OPM Director Scott Kupor added his regular Friday post to his OPM blog today after adding an insightful special post yesterday about the combined federal campaign. This Friday’s post concerns artificial intelligence.
  • MedTech Dive reports,
    • “A bipartisan bill introduced in Congress this week aims to more accurately determine Medicare reimbursement for laboratories by tying payment rates for diagnostic tests to a not-for-profit commercial claims database.
    • “The legislation would reform the 2014 Protecting Access to Medicare Act, also known as PAMA, which the lab industry for years has argued created a process that sets reimbursement rates artificially low.
    • “Called the Reforming and Enhancing Sustainable Updates to Laboratory Testing Services (RESULTS) Act, the new bill would “dramatically improve” the data used to set rates for lab tests, the American Clinical Laboratory Association said Thursday.”
  • OPM released on the Federal Register’s Public Inspection List a final rule titled “Assuring Responsive and Accountable Federal Executive Management. Here’s the summary of the rule,
    • “The Office of Personnel Management (OPM) is issuing this final rule to remove the prohibition of a forced distribution of performance rating levels within the Senior Executive Service (SES) as well as eliminate diversity, equity, and inclusion (DEI) language within SES performance management regulations. Governmentwide SES ratings data have consistently shown that most SES receive the highest rating levels (i.e., Levels 4 and 5) despite documented reports of SES failings. Allowing agencies to limit the highest SES rating levels will increase rigor in SES appraisal and lead to a more normalized distribution of SES ratings across the Federal Government.
    • The rule will be published in the Federal Register on September 15.
  • Per an HHS news release.
    • “The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) will hold a meeting on Thursday and Friday, September 18-19, 2025, in Atlanta, GA. * * *
    • “The meeting will be available to the public via live webcast. The link will be available Thursday morning on the ACIP website. 
    • “The September 18-19 meeting draft agenda will be available on the ACIP website.” 
  • The Groom Law Group lets us know,
    • “The HIPAA Security Rule requires covered entities, such as group health plans and health insurance issuers, as well as business associates, to perform a written “security risk assessment” of the potential risks and vulnerabilities to protected health information (“PHI”) maintained on their systems and applications. 
    • Yesterday [September 10], the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) released an updated version of the Security Risk Assessment Tool (“SRA Tool”), which is an easy-to-use interactive application that covered entities and business associates can use to create the required security risk assessment.  The SRA Tool guides users through the required security risk assessment process using a series of multiple-choice questions, providing references and guidance along the way.  The updated SRA Tool offers new features, including a glossary, tips, and a remediation report.  
    • The OCR and Assistant Secretary for Technology Policy will host live webinars with training sessions on September 15 at 12:00 p.m. ET and September 16 at 3:00 p.m. ET.  You can register for the training sessions here.”

From the Food and Drug Administration front,

  • Bloomberg Law reports,
    • “The FDA is signaling fresh control over the promotion of copycat drugs under President Donald Trump’s executive order to rein in pharmaceutical advertising, staking a position in a regulatory gray area around so-called compounded products.
    • “On Tuesday, Trump’s executive order called for “action to ensure transparency and accuracy in direct-to-consumer prescription drug advertising.” 
    • “The Food and Drug Administration then sent hundreds of letters to drug companies warning of deceptive promotions, which included notices to online telehealth companies that market the compounded products, a spokesperson for the US Department of Health and Human Services said in an email. 
    • “The FDA is clearly looking to take a more aggressive stance with deceptive advertising practices, and that will include non-traditional targets,” said Melissa Wong, a life sciences attorney at Holland & Knight.”
  • STAT News tells us,
    • “Mark your calendars — the Food and Drug Administration will soon convene experts to discuss challenges around regulating mental health products that use artificial intelligence. The announcement arrives as a growing number of companies release chatbots powered by large language models with unpredictable output.
    • “Notice of the Nov. 6 meeting of the Digital Health Advisory Committee, published Thursday in the Federal Register, says newly released mental health products using AI pose “novel risks and, as mental health devices continue to evolve in complexity, regulatory approaches ideally will also evolve to accommodate these novel challenges.” 
    • “The agency has yet to provide clear guidance on how it plans to regulate these devices or what developers must do to show they are safe and effective. But it’s clear the risks are real, as I detailed in my story last week about ChatGPT and other generative AI tools driving users into delusional spirals. Read more from STAT’s Mario Aguilar.”
  • Per an FDA news release,
    • “The U.S. Food and Drug Administration today announced the launch of the FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, an interactive tool designed to facilitate the public’s ability to query real-time adverse event data on cosmetic products. The user-friendly platform allows users to download report listings or data sets, with reports being updated daily to include the most recent submissions.
    • “Today’s launch marks another step in the FDA’s modernization strategy, which includes radical transparency. It follows the agency’s recent announcement on real-time reporting of adverse event and medication errors data for drugs and therapeutic biologics.” * * *
    • Reports in this dashboard have not been verified by the FDA, and their publication does not indicate that the FDA has concluded the product caused the adverse event. Additionally, the FAERS data is not an indicator of the safety profile of the cosmetic product. To learn more, read the frequently asked questions.
  • On a related note, the Wall Street Journal discusses health concerns raised about gel manicures.

From the judicial front,

  • Fierce Pharma notes,
    • “It was another swing and a miss for the biopharma industry on Thursday, when a federal appeals court in Philadelphia unanimously rejected (PDF) a challenge by Novartis on the legality of the Inflation Reduction Act (IRA) Medicare price negotiation program.
    • “It was the second time this month that the U.S. Court of Appeals for the Third Circuit swatted away an IRA challenge from Big Pharma. Last week, the same three-judge panel turned back (PDF) an appeal from Bristol Myers Squibb and Johnson & Johnson, although that decision was split.
    • “Judge Thomas Hardiman, a George W. Bush appointee, registered a dissenting opinion in the appeal brought by BMS and J&J. The other judges on the panel are Joseph Biden appointee Arianna Freeman and Donald Trump appointee Peter Phipps.”
  • Beckers Payer Issues points out,
    • “The U.S. Bankruptcy Court for the Middle District of Florida has approved a bid from Humana’s CenterWell to acquire the assets of The Villages Health, the health system serving The Villages retirement community in Florida.
    • “TVH filed for Chapter 11 bankruptcy in July. The court’s Sept. 9 decision allows the organizations to move forward with the transaction, which is expected to close in the fourth quarter, pending regulatory approvals, according to a Sept. 9 news release.
    • “The deal will bring TVH’s eight primary care centers and two specialty care centers serving more than 55,000 patients under CenterWell. CenterWell operates as a payor-agnostic provider, so TVH patients will be able to continue using their current insurance plans after the transition.”

From the public health and medical/Rx research front,

  • The Centers for Disease Control and Prevention announced today,
    • “COVID-19 activity is peaking in many areas of the country with elevated emergency department visits and hospitalizations nationally. Seasonal influenza activity is low, and RSV activity is very low.
    • “COVID-19
      • “The percentage of COVID-19 laboratory tests that are positive is peaking nationally. “Emergency department visits for COVID-19 are highest in children 0-4 years old and elevated in children 5-17 years old and adults 65 years and older. Hospitalizations numbers are elevated in adults 65 years and older.”
    • “Influenza
    • “RSV
      • “RSV activity is very low.
    • “Vaccination
      • “RSV immunization products will be available beginning in September across most of the continental United States. To protect against RSV-associated lower respiratory tract infections, all infants should receive either maternal RSV vaccination during pregnancy or a long-acting RSV monoclonal antibody, nirsevimab or clesrovimab.
      • “A CDC MMWR report published on August 28, 2025, outlines recommendations from the Advisory Committee on Immunization Practices (ACIP) regarding the use of clesrovimab for preventing severe RSV-related illness in infants. Clesrovimab could further increase access to and protection of infants in the 2025–26 respiratory virus season.
      • “Recommendations for use of 2025-2026 seasonal influenza vaccine have also been published in CDC’s MMWR.”
  • The American Hospital News informs us,
    • “The flu hospitalization rate during the 2024-25 flu season was the highest since 2010-11, according to a report published Sept. 12 by the Centers for Disease Control and Prevention. For all age groups, flu hospitalization rates were 1.8 to 2.8 times higher than median historical rates. Like previous seasons, most hospitalized patients (89%) had one or more underlying medical conditions, nearly 17% were admitted to an intensive care unit, 6% received assistance from a mechanical ventilator and 3% died while in the hospital.
    • “Additionally, the CDC said 32% of hospitalized patients received a flu vaccine and nearly 85% received antiviral treatment. Children and adolescents aged 5-17 received the lowest proportion of antiviral treatment at approximately 62%. The CDC recommended that all individuals older than six months receive a flu vaccine annually.”
  • The New York Times adds that a “Rare but Serious Complication Shows Flu’s Potential Harm, Acute necrotizing encephalopathy, or A.N.E., can result from influenza or other infections, including Covid-19.”
  • Health Day notes that “Comorbidities are seen less often in severe respiratory syncytial virus (RSV) infection in infants younger than 3 months compared with older children, according to a study published online Sept. 9 in The Lancet Regional Health: Europe.”
  • Per the University of Minnesota’s CIDRAP,
    • “The Los Angeles County Department of Public Health (LADPH) yesterday urged residents to make sure family members are protected from measles following the death of a school-age child who was infected with the virus during infancy and developed a rare complication from the disease called subacute sclerosing panencephalitis (SSPE). Health officials said SSPE is typically fatal in people who were infected with measles during early life.” * * *
    • “In related news, the Georgia Department of Public Health today announced another measles case, which involves an unvaccinated Fulton County resident who has no known history of international travel. The patient is no longer infectious but may have exposed others from September 2 to September 11. 
    • “Some of the exposure locations include Georgia State University, a restaurant on multiple days, and soccer games and practices.”
  • Per a National Institutes of Health press release,
    • “According to a study funded by the National Institutes of Health (NIH), older Americans with chronic low back pain who received acupuncture had greater improvement in physical function and reduced pain than those who received usual medical care only, generally prescribed medications or physical therapy. Chronic low back pain is the leading cause of disability worldwide and affects over one-third of older adults in the United States. Treatment options range from pain-relieving drugs to complementary therapies, including acupuncture. There is an urgent need for safe, effective, and non-addictive pain management approaches.
    • “Of the different treatments we have for chronic low back pain, most have a somewhat modest effect. They often reduce pain by about a third at best and can help people function better,” said lead author Lynn L. DeBar, Ph.D., Kaiser Permanente distinguished investigator. “Our clinical results suggests that acupuncture is working as well as many things that are more familiar to people. We found that the size of this effect, while modest, was positive and sustained.”
  • The Washington Post relates,
    • “Exercising muscles pumps out substances that can suppress the growth of breast cancer cells, according to an important new study of exercise and cancer.
    • “The study, published last month, involved 32 women who’d survived breast cancer. After a single session of interval training or weightlifting, their blood contained higher levels of certain molecules, and those factors helped put the brakes on laboratory-grown breast cancer cells.
    • “Our work shows that exercise can directly influence cancer biology, suppressing tumor growth through powerful molecular signals,” said Robert Newton, the deputy director of the Exercise Medicine Research Institute at Edith Cowan University in Perth, Australia, and senior author of the new study.”
  • Per the AHA News,
    • “A Gallup report published Sept. 9 found that nearly 48 million Americans currently have or are being treated for depression. The total, which equals 18.3% of the population, has significantly increased since 2019 (12.5%). The rate increased to 13.8% in 2020 — the onset of the COVID-19 pandemic — and continued to sharply increase. Adults who report having been diagnosed with depression in their lifetime are at 28.5%, nearing the record high of 29% recorded in the first quarter of 2023. The report said that reduced stigma in seeking mental health treatment may partly explain rising depression diagnoses, as 70% of Americans now prefer that their doctor ask about both physical and mental health concerns.”
  • BioPharma Dive lets us know that “signs point to potential benefits of GLP-1s in oncology. Early academic research suggests various ways weight loss drugs could have an impact in cancer care.”

From the U.S. healthcare business front,

  • The Employee Benefits Reseach Institute informs us,
    • “There were 13.1 million individuals with health care claims having employment-based benefits in 2022. However, the use of health care services is far from evenly distributed across the population. In fact, a small portion of the population accounts for a disproportionately large share of health care spending. These “high users” often have significant and complex medical needs and usually require ongoing or intensive care for one or more medical conditions. This Fast Fact is the second in a series of EBRI Fast Facts related to the concentration of health care spending and examines health care spending among individuals in employment-based health plans with the top medical conditions.”
  • Willis Towers Watson calls attention to the fact that “high-cost claims are rising fast, driven by complex conditions and specialty drugs. Employers must shift to data-driven, clinically focused strategies to manage risk and improve outcomes.”
  • Milliman explains “how to build a long-range GLP-1 forecast with the goal of estimating when could commercial health plans see a plateau?”
    • “In recent years, new treatment options for type-2 diabetes and obesity have resulted in substantial changes in clinical guidelines and prescribing patterns. Commercial payers have experienced a recent surge in the utilization of glucagon-like-peptide-1 (GLP-1) medications. Also, approved indications are expanding, including those for sleep apnea and cardiovascular conditions. This white paper provides a framework for building a long-range forecast and can help employers covering these drugs understand how trends associated with these drugs may change over time.”
  • Per Health Affairs Forefront,
    • “Industry and HHS should collaborate to develop a voluntary standardized identifier for provider networks that is consistent across all segments of the health insurance markets. To accomplish this, we propose convening a working group within an accredited standards body or industry collaboration to define the details of the standard and oversee implementation.
    • “This article examines how the lack of standardized identifiers for provider networks creates many frustrations for consumers and other health care stakeholders. It also reviews the role that standardized identifiers and standards bodies play in developing seamless consumer experiences in other industries and the roles they could play in health care in assisting consumers and other stakeholders.”
  • Beckers Hospital Review warns,
    • “Seven-hundred and fifty-nine rural U.S. hospitals are at risk of closure due to financial problems, with about 40% of those hospitals at immediate risk of closure.
    • “The counts are drawn from the Center for Healthcare Quality and Payment Reform’s most recent analysis, based on hospitals’ latest cost reports submitted to CMS and verified as current through August 2025. The analysis identifies two distinct tiers of rural hospital vulnerability: those at risk of closure and those facing an immediate risk of closure.”

Thursday report

David Ermer–CDC, CMS, Congress, FDA, Federal employment benefits, Generative AI, Medical / Rx research, Medicare, OPM, U.S. Healthcare–

From Washington, DC,

  • The Washington Post reports,
    • “Republicans moved Thursday to speed up Senate confirmation of President Donald Trump’s nominees by changing the chamber’s rules over the objections of Democrats.
    • “Senators voted 53-45 to allow themselves to change the rules with a simple majority instead of 60 votes — a move known as the “nuclear option.”
    • “The rules change will allow the Senate to confirm multiple people at once, helping to clear a backlog of nearly 150 nominees awaiting floor votes. Republicans argue it is necessary because Democrats have held up the confirmation process by forcing time-consuming votes on each nominee rather than allowing some of them to be confirmed by voice votes, which is faster.
    • “The change excludes Cabinet officials, Supreme Court justices and federal judges, who must be confirmed one by one.”
  • Per an OPM news release,
    • “The U.S. Office of Personnel Management (OPM) announces the 2025 Combined Federal Campaign (CFC), running from October 1, 2025, to December 31, 2025. The CFC provides federal employees and military personnel opportunities to support charitable causes.
    • “OPM supports the generosity of federal employees but is reviewing the program’s administrative costs and declining participation for potential changes in 2026. Read more in OPM Director Scott
    • “Kupor’s latest blog here and read the memo to agencies here.”
  • OPM Director Scott Kupor explains in his blog,
    • “Over the years, participation in the program has continued to decline from its peak – donations have been hovering around $65-70 million over the past few years. At the same time, the costs to administer the program have continued to increase. This year, the Office of Personnel Management (OPM) estimates the program will consume $22 million in outside contractor fees and listing fees to administer the program.
    • “This means for every $1 a federal employee donates, about $0.33 (or 33%) does not reach the charity for which it was intended. Rather, dollars that could be deployed to help sick children, help veterans in need, or help victims of natural disasters get back on their feet, are instead diverted to overhead. * * *
    • “Despite all of this, we at OPM will shortly launch the 2025 CFC, only because many charities have already spent time and money preparing for this over the course of this year. We hope 2025 will be a successful campaign.
    • “But, at the same time, OPM is concerned about excessive administrative costs associated with the CFC, along with steadily declining participation, and it is evaluating changes to the CFC for 2026 (including whether to continue the program).
    • “We believe strongly in charities and in the generosity that Americans continue to show in donating in support of charities – roughly 50% of American households donate. But we also believe donors expect their dollars to benefit the very causes they intend to support and not to lose the effectiveness of their donations because of excessive administrative costs.”      
  • Tammy Flanagan, writing in Govexec, explains what to know before setting your 2026 retirement date.
  • CNBC reports,
    • “Millions of Social Security beneficiaries may see a 2.7% to 2.8% increase to their monthly checks in 2026, according to new estimates based on the latest government inflation data.
    • “A 2.8% Social Security cost-of-living adjustment may go into effect next year, estimates Mary Johnson, an independent Social Security and Medicare policy analyst. That increase would push the average retirement benefit up by about $54.70 per month, she said. * * *
    • “Those estimated increases would be up from the 2.5% boost to benefits that went into effect in 2025. The COLA has averaged 2.6% over the past 20 years, according to the Senior Citizens League.”
    • “The COLA projections are based on new consumer price index data for the month of August that was released Thursday.
    • “The official Social Security cost-of-living adjustment will include one more month of inflation data.”
  • The American Hospital News tells us,
    • “The Federal Trade Commission announced yesterday that it sent letters to many large health care employers and staffing firms, urging them to review their employment agreements — including any noncompete agreements — to ensure they are in compliance. The commission’s announcement follows one from Sept. 5, when it moved to vacate a 2024 noncompete final rule, voting 3-1 to dismiss appeals initiated by the previous administration attempting to uphold it. On Sept. 4, the FTC issued a request for information on noncompete agreements, seeking to “better understand the scope, prevalence, and effects of employer noncompete agreements, as well as to gather information to inform possible future enforcement actions.”
    • The public comment deadline is November 3, 2025.
  • Healthcare Dive informs us,
    • “The 340B drug discount program incentivizes hospitals to purchase outpatient clinics and prescribe more and higher-cost drugs — behaviors that tend to increase costs for the federal government and commercial health plans, according to a new report from the nonpartisan Congressional Budget Office.
    • “Only one-third of the sharp growth in 340B spending since 2010 is due to rising drug costs and higher prescribing of more expensive drugs, the CBO estimates. Instead, the growth has mostly been fueled by hospitals acquiring off-site clinics and contracting with more independent pharmacies, along with more providers becoming eligible for 340B.
    • “Though the CBO stressed it doesn’t have enough data to quantify the influence of each factor individually, the agency believes that the biggest driver of snowballing 340B growth is probably hospital-clinic M&A.”

From the Food and Drug Administration front,

  • BioPharma Dive tells us,
    • “Senior Food and Drug Administration official Vinay Prasad has reclaimed a role as the agency’s top doctor and scientist six weeks after his dramatic departure and one month after his surprising return to lead the regulator’s biologics medicine division.
    • “On the FDA’s website, Prasad, a physician and prolific researcher, is now listed as the agency’s chief medical and scientific officer in addition to his role as director of the Center for Biologics Evaluation and Research, or CBER. A spokesperson for the Department of Health and Human Services, the FDA’s parent agency, confirmed via email Prasad’s reappointment to his former role.
  • MedTech Dive adds,
    • “Patient groups called for substantial changes to medical device user fees in comments submitted to the Food and Drug Administration. Negotiations recently kicked off for the medical device user fee amendments, which will determine how much funding the FDA’s device center can collect from the industry in fiscal years 2028 through 2032.
    • “After a public hearing last month, clinicians and patient groups submitted comments calling for an increase to user fees, bolstering FDA staffing and more emphasis on product safety. They also called for greater transparency around negotiations and for patients to have more input on the final agreement. 
    • “The FDA received a total of 27 comments by Sept. 4, including several submissions from patients and medical groups. Two large medtech industry lobbying firms, Advamed and the Medical Device Manufacturers Association, which had opposed user fee hikes in the public hearing, had not posted comments as of Thursday.”
  • Beckers Hospital Review provides us with an update on State actions to expand access to the Covid vaccine.

From the public health and medical/Rx research front,

  • The New York Times reports,
    • “Chronic diseases like heart disease, cancer and diabetes are some of the leading causes of death around the world. A new global study shows that deaths from such “noncommunicable” conditions have been declining in most countries — but the pace of that decline, including in high-income countries like the United States, has slowed in recent years.
    • “The probability of dying from a chronic disease between birth and age 80 dropped in about 150 countries from 2010 to 2019, the study, published Wednesday in The Lancet, found. But compared to the previous decade, there was a widespread slowdown — in some cases, even a reversal — in progress.
    • “In the United States, the overall probability of dying from a chronic disease fell markedly between 2001 and 2010 but remained nearly flat over the following nine years. Among younger adults (20 to 45 years old), this probability increased — a rarity among high-income countries. The chance of dying specifically from neuropsychiatric conditions like Alzheimer’s disease and alcohol and drug use disorders also rose in the United States during this period.””
  • Cardiovascular Business notes,
    • “Diets that prioritize plant-based foods while limiting meat and dairy products are associated with reduced risks of all-cause mortality, cardiovascular disease (CVD), coronary heart disease, stroke and diabetes. 
    • “That was the primary takeaway from a new study of more than 3.4 million adults who participated in the National Health and Nutrition Examination Survey (NHANES), UK Biobank or one of 37 different clinical trials. The full analysis was published in Science Advances.” * * *
    • Click here to read the full study.
  • The Hill points out,
    • A DermaRite Industries hand soap recall has been expanded to more than 30 products, including deodorant, lotions, shampoo, hand sanitizer and more.
    • The recall was initiated in July and was expanded recently over concerns that more of its products may include Burkholderia cepacia complex. Exposure to the bacterium could “result in serious and life-threatening infections,” the company said in a release.”
    • “For healthy individuals with minor skin lesions, the use of the product may result in local infections, whereas in immunocompromised individuals the infection could spread into the blood stream, potentially leading to life-threatening sepsis,” the release noted.
    • “Symptoms of bacteria exposure include fever, fatigue and possible respiratory infections for patients with compromised immune systems, according to the Centers for Disease Control and Prevention (CDC).
    • “The products were distributed nationwide in the U.S., including Puerto Rico.”
  • The Wall Street Journal reports,
    • “More women are using cannabis during pregnancy, driven by fears about prescription drugs and beliefs it’s safe for conditions like nausea.
    • “Research on cannabis use during pregnancy is limited, but recent studies suggest potential risks to fetal brain development.
    • “Dispensary practices and conflicting advice from various sources add to confusion, highlighting the need for more research.”
  • BioPharma Dive relates,
    • “Capsida Biotherapeutics has suspended a recently begun clinical trial of an experimental gene therapy after the first participant in the study died following treatment.
    • “Capsida disclosed the death in a letter Wednesday to the patient community for the rare neurodevelopmental disease its gene therapy is designed to treat. In it, the biotechnology company noted it has informed the Food and Drug Administration and will soon provide regulators a full report of the patient’s death.
    • “We understand this devastating news will raise questions and uncertainty, and we are working with urgency to gather information and find answers,” Capsida wrote in its letter.”
  • Per Fierce Pharma,
    • “Approved 15 months ago as a pneumococcal disease vaccine for adults—and billed as the first shot designed for seniors—Merck’s Capvaxive now has data supporting its potential in children and adolescents.
    • “In a phase 3 study of 882 participants aged 2 through 17 who have completed a primary pediatric pneumococcal vaccination regimen and have one or more chronic medical conditions that put them at an increased risk of the respiratory disorder, Capvaxive made the grade in three key measures.”
  • Per Medscape
    • Pavani Chalasani, MD, MPH, is professor of medicine and director of the Division of Hematology/Oncology at The George Washington University. In this interview, Chalasani discusses how liquid biopsies are used to guide therapy in breast cancer and reviews the role of antibody-drug conjugates in current practice.

From the U.S. healthcare business front,

  • The Wall Street Journal relates,
    • “AbbVie has struck a deal with generic drugmakers aimed at extending patent protection for its blockbuster autoimmune drug Rinvoq well into the next decade.
    • “AbbVie on Thursday said it has settled litigation with all generic manufacturers that have filed applications with the Food and Drug Administration for generic versions of Rinvoq, which is approved for use in several autoimmune diseases.
    • “The North Chicago, Ill., biopharmaceutical company said it now doesn’t expect any U.S. generic entry for Rinvoq prior to April 2037, given the settlement and license agreements and assuming the company wins pediatric exclusivity.
    • “Analysts at William Blair, who had previously assumed a 2033 loss of U.S. patent exclusivity for Rinvoq, said the settlements are a big win for AbbVie that support longer-term protection for the franchise.”
  • STAT News reports,
    • “Consumers can now purchase Exact Sciences’ liquid biopsy early detection test, Cancerguard, and get an indication of whether they might have one of 50 different cancers included in the test’s analysis. The biotechnology company launched the test on Wednesday, and Tom Beer, Exact’s chief medical officer, relayed the news with elation.
    • “I am feeling fantastic. This is what I came to Exact to do,” Beer said. A practicing oncologist, Beer said that he’s reminded every Friday in clinic of the world of difference that catching cancer early can make. The promise of liquid biopsy tests is to do that for dozens of cancers, not just breast, prostate, colorectal, lung, and cervical cancer.”
  • Per Modern Healthcare,
    • “CVS Health has named Jon Thiboutot as president of retail health, effective immediately.
    • “Thiboutot was most recently vice president of operations at CVS MinuteClinic. He succeeds Dr. Creagh Milford, who had served as interim president of retail health since May and will continue to lead primary care provider Oak Street Health, CVS said Thursday.
    • “A CVS spokesperson declined to say whether the company will fill Thiboutot’s former role.”
  • and
    • “The American Medical Association released nearly 300 new Current Procedural Terminology billing codes Thursday as part of its proposed 2026 code set.
    • “Two other codes can be used to report remote monitoring treatment management after 10 minutes of services per calendar month, down from 20 minutes, according to an AMA news release. 
    • “Several augmented and artificial intelligence services were also included in the new code updates, ranging from tools that assess coronary disease to burn wound classification, according to the release. 
    • “The updates signal potential broader acceptance and reimbursement for digital health services in standard billing codes.
    • “The AMA’s CPT Editorial Panel organizes the association’s CPT code system, which is used in billing and reimbursement by the Centers for Medicare and Medicaid Services, as well as other payers and providers. CMS and others have the option to adopt the changes and put them into effect starting Jan. 1.” 
  • Beckers Hospital Review informs us
    • “The District of Columbia holds the highest ratio of nurses to population, to a significant degree, at 7.14 per 100 residents, while Utah has the lowest, at 1.38, according to a Becker’s analysis. [The full list is displayed in the article.]
    • “The analysis is based on U.S. Census Bureau state population estimates as of July 1, 2024, and active registered nurse and practical nurse license counts from the National Council of State Boards of Nursing database. The number of nurses per 100 residents was calculated by dividing the total number of active licenses in each state by its population and multiplying by 100. In California, the total reflects RN and vocational nurse licenses, rather than PN.”
  • and
    • “Landmark Hospital of Cape Girardeau (Mo.), a long-term acute care facility, has shared plans to close “in the coming weeks,” according to a Sept. 10 news release.
    • “The hospital has been open since early 2006 and is part of Cape Girardeau-based Landmark Holdings of Florida, which operates six long-term acute care hospitals across the U.S. The hospital operator sought Chapter 11 protection in early March and plans to find buyers for its facilities to relieve mounting financial challenges.”